Trial Outcomes & Findings for Identifying the Optimal Neural Target for Misophonia Interventions (NCT NCT04348591)
NCT ID: NCT04348591
Last Updated: 2023-08-25
Results Overview
HF-HRV was extracted from 2 minute blocks during which participants engage in a behavioral strategy (listen or downregulate emotions using cognitive restructuring), while listening to neutral, aversive, and misophonic sounds and receive active or sham neurostimulation. The results represent the average HF-HRV during experimental blocks. The raw values were transformed using a logarithmic function to preserve the normality assumption.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
Two minute blocks during the neurostimulation experimental session during which participants listened to or downregulated emotions associated with experimental sounds (45 minutes total).
Results posted on
2023-08-25
Participant Flow
Participants were recruited through online websites (e.g., Craigslist, Dukelist), social media (Facebook, Instagram, Reddit), flyers, and electronic medical record outreach. Participants reached the study predominantly by seeing advertisements on social media and research websites. Many participants who met the severity cutoff for misophonia also found the study via self-guided internet search.
Top reasons for not qualifying included emotion dysregulation \& misophonia severity too low; too low severity for misophonic group, but too many misophonic symptoms for control group; moderate/severe current alcohol or substance use disorder; TMS/MRI contraindications; or could not provide usable MRI data.
Participant milestones
| Measure |
Misophonia Group
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to misophonic, aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to misophonic, aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Imaging Session (120 Min)
STARTED
|
29
|
30
|
|
Imaging Session (120 Min)
COMPLETED
|
27
|
27
|
|
Imaging Session (120 Min)
NOT COMPLETED
|
2
|
3
|
|
CR Training (45 Min)
STARTED
|
27
|
27
|
|
CR Training (45 Min)
COMPLETED
|
27
|
27
|
|
CR Training (45 Min)
NOT COMPLETED
|
0
|
0
|
|
Experimental Task (45 Min)
STARTED
|
27
|
27
|
|
Experimental Task (45 Min)
Completed Sham rTMS Experimental Condition
|
26
|
27
|
|
Experimental Task (45 Min)
Completed HF rTMS Over the Right dlPFC Experimental Condition
|
26
|
27
|
|
Experimental Task (45 Min)
Completed LF rTMS Over the Right mPFC Experimental Condition
|
27
|
27
|
|
Experimental Task (45 Min)
COMPLETED
|
27
|
27
|
|
Experimental Task (45 Min)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Misophonia Group
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to misophonic, aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to misophonic, aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Imaging Session (120 Min)
Lost to Follow-up
|
0
|
2
|
|
Imaging Session (120 Min)
Physician Decision
|
0
|
1
|
|
Imaging Session (120 Min)
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Identifying the Optimal Neural Target for Misophonia Interventions
Baseline characteristics by cohort
| Measure |
Misophonia Group
n=29 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=30 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.59 years
STANDARD_DEVIATION 9.79 • n=5 Participants
|
27.07 years
STANDARD_DEVIATION 8.28 • n=7 Participants
|
28.31 years
STANDARD_DEVIATION 9.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
misophonia questionnaire Subscale 1
|
2.86 units on a scale
STANDARD_DEVIATION 0.43 • n=5 Participants
|
1.37 units on a scale
STANDARD_DEVIATION 0.87 • n=7 Participants
|
2.10 units on a scale
STANDARD_DEVIATION 1.02 • n=5 Participants
|
|
misophonia questionnaire Subscale 2
|
2.83 units on a scale
STANDARD_DEVIATION 0.38 • n=5 Participants
|
1.08 units on a scale
STANDARD_DEVIATION 0.69 • n=7 Participants
|
1.97 units on a scale
STANDARD_DEVIATION 1.04 • n=5 Participants
|
|
misophonia questionnaire severity
|
9.18 units on a scale
STANDARD_DEVIATION 1.63 • n=5 Participants
|
3.45 units on a scale
STANDARD_DEVIATION 2.47 • n=7 Participants
|
6.26 units on a scale
STANDARD_DEVIATION 3.56 • n=5 Participants
|
|
Difficulties in emotion regulation scale
|
108.16 units on a scale
STANDARD_DEVIATION 24.69 • n=5 Participants
|
117.17 units on a scale
STANDARD_DEVIATION 16.39 • n=7 Participants
|
112.83 units on a scale
STANDARD_DEVIATION 21.11 • n=5 Participants
|
PRIMARY outcome
Timeframe: Two minute blocks during the neurostimulation experimental session during which participants listened to or downregulated emotions associated with experimental sounds (45 minutes total).Population: Participants who completed the study.
HF-HRV was extracted from 2 minute blocks during which participants engage in a behavioral strategy (listen or downregulate emotions using cognitive restructuring), while listening to neutral, aversive, and misophonic sounds and receive active or sham neurostimulation. The results represent the average HF-HRV during experimental blocks. The raw values were transformed using a logarithmic function to preserve the normality assumption.
Outcome measures
| Measure |
Misophonia Group
n=27 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=27 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
listen to neutral sound+ sham stimulation
|
1.8903 lg(ms^2)
Standard Deviation .49961
|
1.9422 lg(ms^2)
Standard Deviation .51434
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
listen to a neutral sound+ HF rTMS stimulation
|
1.9420 lg(ms^2)
Standard Deviation .47814
|
1.9465 lg(ms^2)
Standard Deviation .52974
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
listen to a neutral sound+ LF rTMS
|
1.8923 lg(ms^2)
Standard Deviation .4136
|
1.9771 lg(ms^2)
Standard Deviation .61184
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
listen to an aversive sound+sham stimulation
|
1.9172 lg(ms^2)
Standard Deviation .44301
|
1.9151 lg(ms^2)
Standard Deviation .49276
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
listen to an aversive sound+ HF rTMS
|
1.9753 lg(ms^2)
Standard Deviation .45907
|
2.0791 lg(ms^2)
Standard Deviation .58066
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
listen to an aversive sound + LF rTMS
|
1.8942 lg(ms^2)
Standard Deviation .44218
|
1.9590 lg(ms^2)
Standard Deviation .62018
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
listen to a misophonic sound + sham stimulation
|
1.8920 lg(ms^2)
Standard Deviation .44746
|
1.8868 lg(ms^2)
Standard Deviation .58837
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
listen to a misophonic sound + HF rTMS
|
1.9680 lg(ms^2)
Standard Deviation .43347
|
2.0457 lg(ms^2)
Standard Deviation .55137
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
listen to a misophonic sound + LF rTMS
|
1.8289 lg(ms^2)
Standard Deviation .48734
|
1.9392 lg(ms^2)
Standard Deviation .61046
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
downregulate emotions during aversive sounds + sham stimulation
|
1.9216 lg(ms^2)
Standard Deviation .46655
|
1.9390 lg(ms^2)
Standard Deviation .61942
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
downregulate emotions during aversive sounds + HF rTMS
|
1.9319 lg(ms^2)
Standard Deviation .45462
|
2.0262 lg(ms^2)
Standard Deviation .55149
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
downregulate emotions during aversive sounds + LF rTMS
|
1.8740 lg(ms^2)
Standard Deviation .45462
|
1.9669 lg(ms^2)
Standard Deviation .64162
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
downregulate emotions during misophonic sounds + sham stimulation
|
1.9290 lg(ms^2)
Standard Deviation .47660
|
1.9362 lg(ms^2)
Standard Deviation .56408
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
downregulate emotions during misophonic sounds + HF rTMS
|
1.9259 lg(ms^2)
Standard Deviation .46639
|
1.9962 lg(ms^2)
Standard Deviation .57097
|
|
Physiological Outcome: High Frequency Heart Rate Variability (HF-HRV) Recorded During Experimental Blocks
downregulate emotions during misophonic sounds + LF rTMS
|
1.8882 lg(ms^2)
Standard Deviation .48890
|
1.9281 lg(ms^2)
Standard Deviation .58576
|
PRIMARY outcome
Timeframe: Two minute blocks during the neurostimulation experimental session (when participants listened to or downregulated emotions associated with experimental sounds)Population: Participants who completed the study.
Physiological arousal measured by SCL during each experimental block was extracted using Acqknowledge software and BIOPAC hardware (during the neurostimulation session). Raw galvanic skin response was continuously collected throughout the experiment. Raw data was then examined for abrupt changes (skin conductance responses), which were removed. The processed data was then averaged for each two minute experimental block. Higher SCL means higher arousal.
Outcome measures
| Measure |
Misophonia Group
n=27 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=27 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Skin Conductance Level (SCL)
listen to neutral sounds + sham stimulation
|
8.42392 microsemens
Standard Deviation 3.228892
|
8.90082 microsemens
Standard Deviation 5.259539
|
|
Skin Conductance Level (SCL)
listen to neutral sounds + HF rTMS
|
8.51538 microsemens
Standard Deviation 3.820940
|
9.30579 microsemens
Standard Deviation 5.232129
|
|
Skin Conductance Level (SCL)
listen to neutral sounds + LF rTMS
|
8.39378 microsemens
Standard Deviation 3.569227
|
8.83644 microsemens
Standard Deviation 5.731341
|
|
Skin Conductance Level (SCL)
listen to aversive sounds + sham stimulation
|
9.18323 microsemens
Standard Deviation 3.275174
|
9.40404 microsemens
Standard Deviation 5.249783
|
|
Skin Conductance Level (SCL)
listen to aversive sounds + HF rTMS
|
9.56538 microsemens
Standard Deviation 4.100446
|
10.45648 microsemens
Standard Deviation 5.395880
|
|
Skin Conductance Level (SCL)
listen to aversive sounds + LF rTMS
|
9.41889 microsemens
Standard Deviation 3.675953
|
9.51379 microsemens
Standard Deviation 5.677760
|
|
Skin Conductance Level (SCL)
listen to misophonic sounds + sham stimulation
|
8.83446 microsemens
Standard Deviation 3.160085
|
9.17171 microsemens
Standard Deviation 5.249371
|
|
Skin Conductance Level (SCL)
listen to misophonic sounds + HF rTMS
|
8.68612 microsemens
Standard Deviation 3.446615
|
9.68599 microsemens
Standard Deviation 5.220985
|
|
Skin Conductance Level (SCL)
listen to misophonic sounds + LF rTMS
|
8.89759 microsemens
Standard Deviation 3.950378
|
8.85123 microsemens
Standard Deviation 5.617469
|
|
Skin Conductance Level (SCL)
downregulate distress associated with aversive sounds+ sham stimulation
|
8.5036 microsemens
Standard Deviation 3.5264
|
8.88481 microsemens
Standard Deviation 5.501042
|
|
Skin Conductance Level (SCL)
downregulate distress associated with aversive sounds+ HF rTMS
|
8.51065 microsemens
Standard Deviation 3.714333
|
9.53835 microsemens
Standard Deviation 5.269438
|
|
Skin Conductance Level (SCL)
downregulate distress associated with aversive sounds+ LF rTMS
|
8.34333 microsemens
Standard Deviation 3.567143
|
8.82512 microsemens
Standard Deviation 5.850350
|
|
Skin Conductance Level (SCL)
downregulate distress associated with misophonic sounds+ sham stimulation
|
8.66058 microsemens
Standard Deviation 3.438065
|
8.64721 microsemens
Standard Deviation 5.321361
|
|
Skin Conductance Level (SCL)
downregulate distress associated with misophonic sounds+ HF rTMS
|
8.38327 microsemens
Standard Deviation 3.611908
|
9.37240 microsemens
Standard Deviation 5.049701
|
|
Skin Conductance Level (SCL)
downregulate distress associated with misophonic sounds+ LF rtMS
|
8.43874 microsemens
Standard Deviation 3.658122
|
8.82144 microsemens
Standard Deviation 5.888309
|
PRIMARY outcome
Timeframe: At the end of the neurostimulation session (session 3 in the experiment), which occured within a month of the initial assessmentPopulation: Participants who completed the study
The investigators will record how many participants completed the neurostimulation session as a marker of acceptability.
Outcome measures
| Measure |
Misophonia Group
n=27 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=27 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Behavioral Outcome: Acceptability of Procedures
|
27 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: during the neuroimaging session, within a month of the intake assessmentPopulation: Participants who completed the study.
Blood Oxygenation Level Dependent (BOLD) imaging is a technique that is commonly used for estimating brain activity using functional magnetic resonance imaging (fMRI). Change in the fMRI BOLD signal notes changes in brain blood flow and blood oxygenation, which are associated with neuronal activity. Higher values indicate higher activity changes within a contrast of interes. A dlPFC mask was employed to find the maximum value of the \[downregulate misophonic sounds \> downregulate aversive sounds\] contrast in this region. Once the voxel containing this maximum was identified, a 6 mm sphere ROI was created around this spot (restricted to the dlPFC mask) and the average contrast value within this sphere was used as the outcome variable.
Outcome measures
| Measure |
Misophonia Group
n=27 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=27 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Neuroimaging Outcome: Differential Change in BOLD Signal Between Groups Within the Dorsolateral Prefrontal Cortex (dlPFC), That is Greater During Regulation of Misophonic Versus Non-misophonic Distress
|
.4572 BOLD arbitrary units
Standard Deviation .58605
|
.4288 BOLD arbitrary units
Standard Deviation .32026
|
PRIMARY outcome
Timeframe: during the neuroimaging session, within a month of the intake assessmentPopulation: Participants who completed the study.
Blood Oxygenation Level Dependent (BOLD) imaging is a technique that is commonly used for estimating brain activity using functional magnetic resonance imaging (fMRI). Change in the fMRI BOLD signal notes changes in brain blood flow and blood oxygenation, which are associated with neuronal activity. A vmPFC mask was employed to find the maximum value of the \[downregulate misophonic sounds \> downregulate aversive sounds\] contrast in this region. Once the voxel containing this maximum was identified, a 6 mm sphere ROI was created around this spot (restricted to the vmPFC mask) and the average contrast value within this sphere will be used as the outcome variable. Higher scores indicate more activity when downregulating misophonic versus aversive sounds.
Outcome measures
| Measure |
Misophonia Group
n=27 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=27 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Neuroimaging Outcome: Differential Change in BOLD Signal Within the Ventromedial Prefrontal Cortex (vmPFC) When Engaging in the Regulation of Emotional Versus Misophonic Distress
|
.4967 BOLD arbitrary units
Standard Deviation .61469
|
.5233 BOLD arbitrary units
Standard Deviation .60430
|
PRIMARY outcome
Timeframe: during the neuroimaging session, within a month of the intake assessmentPopulation: Participants who completed the study.
Blood Oxygenation Level Dependent (BOLD) imaging is a technique that is commonly used for estimating brain activity using functional magnetic resonance imaging (fMRI). Change in the fMRI BOLD signal notes changes in brain blood flow and blood oxygenation, which are associated with neuronal activity. An AIC mask was employed to find the maximum value of the \[hear misophonic sounds \> hear aversive sounds\] contrast in this region. Once the voxel containing this maximum was identified, a 6 mm sphere ROI was created around this spot (restricted to the AIC mask) and the average contrast value within this sphere will be used as the outcome variable. A larger score indicates more activity when hearing misophonic versus aversive sounds.
Outcome measures
| Measure |
Misophonia Group
n=27 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=27 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Neuroimaging Outcome: Differential Change in BOLD Signal Within the Anterior Insular Cortex (AIC) Activation When Being Presented With Cues for Emotional Versus Misophonic Distress
|
.3744 BOLD arbitrary units
Standard Deviation .22996
|
.3093 BOLD arbitrary units
Standard Deviation .22876
|
SECONDARY outcome
Timeframe: Baseline, during the experimental blocks during the neurostimulation session (which will occur within a month of the initial assessment)Population: Participants who completed the study.
Self reported distress after experimental blocks will also be examined for differences when accounting for baseline distress (during the neurostimulation session). SUDS will be measured using a 0-9 sale, where 0 indicates no distress, and 9 indicates extreme distress. The outcome measure represents SUDS after negative sound presentations (misophonic and aversive) minus SUDS after baseline. Higher SUDS represents higher distress.
Outcome measures
| Measure |
Misophonia Group
n=27 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=27 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Change in Subjective Units of Distress (SUDS)
listen to neutral sounds + sham stimulation
|
0.2981 units on a scale
Standard Deviation 1.35732
|
0.5370 units on a scale
Standard Deviation 1.25621
|
|
Change in Subjective Units of Distress (SUDS)
listen to neutral sounds + HF rTMS
|
-0.5769 units on a scale
Standard Deviation 1.45277
|
-0.3611 units on a scale
Standard Deviation 1.97866
|
|
Change in Subjective Units of Distress (SUDS)
listen to neutral sounds + LF rTMS
|
-0.2130 units on a scale
Standard Deviation 1.61795
|
0.3056 units on a scale
Standard Deviation 1.33576
|
|
Change in Subjective Units of Distress (SUDS)
listen to aversive sounds + sham stimulation
|
1.3107 units on a scale
Standard Deviation 1.94548
|
2.8795 units on a scale
Standard Deviation 2.18199
|
|
Change in Subjective Units of Distress (SUDS)
listen to aversive sounds + HF rTMS
|
0.6019 units on a scale
Standard Deviation 2.11131
|
1.8505 units on a scale
Standard Deviation 2.21404
|
|
Change in Subjective Units of Distress (SUDS)
listen to aversive sounds + LF rTMS
|
0.8981 units on a scale
Standard Deviation 1.66851
|
2.5463 units on a scale
Standard Deviation 2.25224
|
|
Change in Subjective Units of Distress (SUDS)
listen to misophonic sounds + sham stimulation
|
4.4712 units on a scale
Standard Deviation 2.38505
|
2.3426 units on a scale
Standard Deviation 2.02398
|
|
Change in Subjective Units of Distress (SUDS)
listen to misophonic sounds+ HF rTMS
|
3.3269 units on a scale
Standard Deviation 2.71079
|
0.9815 units on a scale
Standard Deviation 2.28764
|
|
Change in Subjective Units of Distress (SUDS)
listen to misophonic sounds + LF rTMS
|
3.7037 units on a scale
Standard Deviation 2.64490
|
1.9252 units on a scale
Standard Deviation 1.98438
|
|
Change in Subjective Units of Distress (SUDS)
downregulate distress associated with aversive sounds+ sham stimulation
|
0.7184 units on a scale
Standard Deviation 1.59913
|
1.3148 units on a scale
Standard Deviation 1.29448
|
|
Change in Subjective Units of Distress (SUDS)
downregulate distress associated with aversive sounds+ HF rTMS
|
-0.0288 units on a scale
Standard Deviation 1.56079
|
0.1574 units on a scale
Standard Deviation 1.74636
|
|
Change in Subjective Units of Distress (SUDS)
downregulate distress associated with aversive sounds+ LF rTMS
|
0.2685 units on a scale
Standard Deviation 1.27965
|
1.0926 units on a scale
Standard Deviation 1.38441
|
|
Change in Subjective Units of Distress (SUDS)
downregulate distress associated with misophonic sounds+ sham stimulation
|
3.3173 units on a scale
Standard Deviation 2.45845
|
1.0472 units on a scale
Standard Deviation 1.35494
|
|
Change in Subjective Units of Distress (SUDS)
downregulate distress associated with misophonic sounds+ HF rTMS
|
2.0673 units on a scale
Standard Deviation 2.70298
|
-0.2963 units on a scale
Standard Deviation 1.49303
|
|
Change in Subjective Units of Distress (SUDS)
downregulate distress associated with misophonic sounds+ LF rTMS
|
2.50000 units on a scale
Standard Deviation 2.71548
|
0.7778 units on a scale
Standard Deviation 1.38977
|
SECONDARY outcome
Timeframe: From baseline to the end of neurostimulation session, an average of 4 weeks.Population: Some participants dropped out or were lost to contact by follow up.
A self report assessing difficulties regulating emotions will be examined before and after the experiment (i.e., at the end of the neurostimulation session). The DERS ranges from 36 to 180, with higher scores indicating more dysregulation.
Outcome measures
| Measure |
Misophonia Group
n=29 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=30 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Emotional Dysregulation as Measured by the Difficulties in Emotion Regulation Scale (DERS)
Baseline
|
93.04 score on a scale
Standard Deviation 21.17
|
112.43 score on a scale
Standard Deviation 16.42
|
|
Emotional Dysregulation as Measured by the Difficulties in Emotion Regulation Scale (DERS)
End of neurostimulation session
|
88.70 score on a scale
Standard Deviation 21.76
|
99.85 score on a scale
Standard Deviation 17.75
|
SECONDARY outcome
Timeframe: At baselineThe PROMIS-43 is a 43-item questionnaire assessing health status in seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and participation in social roles. Lower scores indicate less impairment in functioning when compared to higher scores. Each item has five response options ranging in value from 1 to 5, except for the 1 Pain Intensity item which has eleven response options ranging in value from 0 to 10. A raw score is created from each domain that makes up the Profile. Each domain raw score ranging from 6-30 corresponds to a T-Score in the PROMIS scoring manual.
Outcome measures
| Measure |
Misophonia Group
n=29 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=30 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Self-reported Health Status as Measured by the Patient Reported Outcome Measurement Information System (PROMIS)-43 Adult Profile
P43 Anxiety
|
14.10 score on a scale
Standard Deviation 5.37
|
13.70 score on a scale
Standard Deviation 5.73
|
|
Self-reported Health Status as Measured by the Patient Reported Outcome Measurement Information System (PROMIS)-43 Adult Profile
P43 Depression
|
11.28 score on a scale
Standard Deviation 6.05
|
13.03 score on a scale
Standard Deviation 6.49
|
|
Self-reported Health Status as Measured by the Patient Reported Outcome Measurement Information System (PROMIS)-43 Adult Profile
P43-Fatigue
|
14.97 score on a scale
Standard Deviation 7.27
|
15.80 score on a scale
Standard Deviation 6.27
|
|
Self-reported Health Status as Measured by the Patient Reported Outcome Measurement Information System (PROMIS)-43 Adult Profile
P43- Sleep disturbance
|
13.24 score on a scale
Standard Deviation 6.26
|
15.30 score on a scale
Standard Deviation 4.83
|
|
Self-reported Health Status as Measured by the Patient Reported Outcome Measurement Information System (PROMIS)-43 Adult Profile
P43- Ability to partake in social roles
|
23.86 score on a scale
Standard Deviation 4.60
|
23.07 score on a scale
Standard Deviation 5.66
|
|
Self-reported Health Status as Measured by the Patient Reported Outcome Measurement Information System (PROMIS)-43 Adult Profile
P43-Pain interference
|
7.59 score on a scale
Standard Deviation 3.09
|
7.93 score on a scale
Standard Deviation 3.11
|
|
Self-reported Health Status as Measured by the Patient Reported Outcome Measurement Information System (PROMIS)-43 Adult Profile
P43-Physical functioning
|
29.76 score on a scale
Standard Deviation 3.11
|
28.73 score on a scale
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: During the neuroimaging session, within a month of the intake assessmentBlood Oxygenation Level Dependent (BOLD) imaging is a technique that is commonly used for estimating brain activity using functional magnetic resonance imaging (fMRI). Change in the fMRI BOLD signal notes changes in brain blood flow and blood oxygenation, which are associated with neuronal activity. The BOLD signal contrast between engaging with aversive sounds and engaging with neutral sounds were compared between groups across the whole brain on a voxel-wise basis. Voxel-wise significant results (i.e., z \> 2.3) were clustered to statistically correct for multiple comparisons. The number of significant clusters that emerged from this analysis in each group are presented as outcome.
Outcome measures
| Measure |
Misophonia Group
n=29 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=30 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Number of Clusters Across the Whole Brain With Significant BOLD Changes Between Groups When Contrasting the Exposure to Aversive Versus Neutral Sounds.
|
0 clusters where differences emerged
|
0 clusters where differences emerged
|
SECONDARY outcome
Timeframe: during the neuroimaging session, within a month of the intake assessmentBlood Oxygenation Level Dependent (BOLD) imaging is a technique that is commonly used for measuring brain activity using functional magnetic resonance imaging (fMRI). Change in a BOLD signal detected in fMRI, notes changes in brain blood flow and blood oxygenation. Neural activation across the brain when engaging with misophonic sounds versus aversive sounds during the neuroimaging day. The BOLD signal contrast between engaging with misophonic sounds and engaging with aversive sounds were compared between groups across the whole brain on a voxel-wise basis. Voxel-wise significant results (i.e., z \> 2.3) were clustered to statistically correct for multiple comparisons. The number of significant clusters that emerged from this analysis in each group are presented as outcome.
Outcome measures
| Measure |
Misophonia Group
n=29 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=30 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Number of Clusters Across the Whole Brain With Significant BOLD Changes Between Groups When Contrasting the Exposure to Misophonic Versus Aversive Sounds.
|
6 clusters
|
3 clusters
|
SECONDARY outcome
Timeframe: during the neuroimaging session, within a month of the intake assessmentBlood Oxygenation Level Dependent (BOLD) imaging is a technique that is commonly used for estimating brain activity using functional magnetic resonance imaging (fMRI). Change in the fMRI BOLD signal notes changes in brain blood flow and blood oxygenation, which are associated with neuronal activity. The BOLD signal contrast between regulating versus engaging with misophonic sounds across the entire brain was compared between participant groups on a voxel-wise basis. Voxel-wise results were clustered to statistically correct for multiple comparisons. The number of significant clusters within each group are presented as outcome (more cluster indicates more differences during regulation in that group versus the control group).
Outcome measures
| Measure |
Misophonia Group
n=29 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=30 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Number of Clusters Across the Whole Brain With Significant BOLD Changes Between Groups When Contrasting the Downregulation of Distress Associated With Misophonic Sounds to Exposure to Misophonic Sounds
|
1 clusters
|
0 clusters
|
SECONDARY outcome
Timeframe: during the neuroimaging session, within a month of the intake assessmentBlood Oxygenation Level Dependent (BOLD) imaging is a technique that is commonly used for estimating brain activity using functional magnetic resonance imaging (fMRI). Change in the fMRI BOLD signal notes changes in brain blood flow and blood oxygenation, which are associated with neuronal activity. The BOLD signal contrast between regulating and engaging with aversive sounds was compared between participant groups on a voxel-wise basis. Voxel-wise results were clustered to statistically correct for multiple comparisons. The number of significant clusters within each group are reported as the outcome measure.
Outcome measures
| Measure |
Misophonia Group
n=29 Participants
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=30 Participants
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Number of Clusters Across the Whole Brain With Significant BOLD Changes Between Groups When Contrasting the Downregulation of Distress Associated With Aversive Sounds to Exposure to AversiveSounds
|
0 clusters
|
0 clusters
|
Adverse Events
Misophonia Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Emotional Dysregulation Clinical Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Misophonia Group
n=27 participants at risk
Participants who endorse Misophonia will undergo a neuroimaging session to identify different neurostimulation targets. Then Misophonic participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
Emotional Dysregulation Clinical Group
n=27 participants at risk
Participants who self report high emotional dysregulation and who meet diagnostic criteria for a DSM disorder will undergo a neuroimaging session to identify different neurostimulation targets. Then these participants will be exposed to aversive and neutral sounds while receiving real or sham neurostimulation over different pre-established neural targets.
Cognitive Restructuring: All participants will learn how to change their thinking in order to be less upset when confronted with stressors
neurostimulation: all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
|
|---|---|---|
|
Nervous system disorders
Headache
|
14.8%
4/27 • Number of events 4 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
0.00%
0/27 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
|
Musculoskeletal and connective tissue disorders
Scalp Pain
|
7.4%
2/27 • Number of events 2 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
11.1%
3/27 • Number of events 3 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
|
Nervous system disorders
Pain
|
3.7%
1/27 • Number of events 1 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
0.00%
0/27 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.00%
0/27 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
3.7%
1/27 • Number of events 1 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
|
Nervous system disorders
Eye Pain
|
3.7%
1/27 • Number of events 1 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
0.00%
0/27 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
|
Infections and infestations
COVID
|
0.00%
0/27 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
3.7%
1/27 • Number of events 1 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
|
Psychiatric disorders
Irritability
|
3.7%
1/27 • Number of events 1 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
0.00%
0/27 • Enrollment through study completion/termination, approximately - 1-2 months.
From intake through study completion, AE/SAEs, distress and risk were assessed as described in the approved DUHS IRB protocol. At the TMS visit, trained study staff queried participants on potential adverse effects that can occur during TMS pre and post TMS- including headache, neck pain, scalp pain, hearing impairment. Most of the AE reported are in relation to neurostimulation visit and only 2 other AEs, not connected to the neurostimulation visit were reported in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place