Trial Outcomes & Findings for Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms (NCT NCT03601117)
NCT ID: NCT03601117
Last Updated: 2022-05-18
Results Overview
A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic). Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of \<10. Data are presented as a raw score point change.
COMPLETED
NA
23 participants
After all stimulation sessions have been completed (approximately 48 hours after the final session)
2022-05-18
Participant Flow
All participants were recruited from Stanford Hospital
23 participants signed informed consent; 22 participants were allocated to a treatment group.
Participant milestones
| Measure |
Dorsolateral Prefrontal Cortex
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
Anterior Cingulate Cortex (ACC)
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
2
|
|
Overall Study
COMPLETED
|
17
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
Baseline characteristics by cohort
| Measure |
Dorsolateral Prefrontal Cortex
n=20 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
Anterior Cingulate Cortex (ACC)
n=2 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
45.55 years
STANDARD_DEVIATION 17.41 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 13.44 • n=7 Participants
|
47.64 years
STANDARD_DEVIATION 18.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic or Latino
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
2 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Baseline MADRS
|
38.5 score on a scale
STANDARD_DEVIATION 6.33 • n=5 Participants
|
29.5 score on a scale
STANDARD_DEVIATION .71 • n=7 Participants
|
37.68 score on a scale
STANDARD_DEVIATION 6.61 • n=5 Participants
|
PRIMARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Only participants who completed the protocol were included in this analysis.
A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic). Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of \<10. Data are presented as a raw score point change.
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
n=1 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=17 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS) Score
|
16 score on a scale
Standard Deviation 0
|
26.59 score on a scale
Standard Deviation 10.32
|
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Only participants who completed the questionnaire were included in this analysis.
19-item clinician administered assessment to measure the intensity, pervasiveness, and characteristics of suicidal ideation in adults. Scores range from 0-38. Higher scores indicate more suicidality. Data are presented as a raw score point change.
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
n=1 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=17 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in Scale of Suicidal Ideation (SSI) Score
|
0 score on a scale
|
9.82 score on a scale
Standard Deviation 9.69
|
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Only participants who completed the protocol were included in this analysis.
Clinical assessment measuring depressive symptoms. Scores range from 0-24 with scores \>5 indicating clinical levels of depressive symptoms (higher scores are more symptomatic). Data are presented as a raw score point change.
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
n=1 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=17 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score
|
1 score on a scale
Standard Deviation 0
|
10 score on a scale
Standard Deviation 4.03
|
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Only participants who completed the protocol were included in this analysis.
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on the patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2). Data are presented as a raw score point change.
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
n=1 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=17 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in Young Mania Rating Scale (YMRS)
|
0 score on a scale
Standard Deviation 0
|
.06 score on a scale
Standard Deviation .43
|
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Only participants who completed the questionnaire were included in this analysis.
The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Scores: 0-13= minimal depression, 14-19=mild depression, 20-28=moderate depression, 29-63=severe depression. Data are presented as a raw score point change.
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
n=1 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=16 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in Beck Depression Inventory II (BDI-II)
|
6 score on a scale
Standard Deviation 0
|
18.88 score on a scale
Standard Deviation 10.76
|
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Only participants who completed the protocol were included in this analysis.
Self-report measure of depressive symptoms. The questionnaire consists of 16 questions. Each question can score between 0 to 4 points. Severity of depression is determined as follows: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Very Severe. Total scores range from 0-27. Total scores: 0-5= no depression, 6-10= mild depression, 11-15= moderate depression, 16-20= severe depression, 21-27= very severe depression. The total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV MDD criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes (Rush et al. 2003). Data are presented as a raw score point change.
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
n=1 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=17 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score
|
6 score on a scale
Standard Deviation 0
|
11.29 score on a scale
Standard Deviation 5.81
|
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Participants who completed this questionnaire were included in the analysis. Participants who do not have this data completed were excluded.
Self-report, 20 item scale to determine patient's insomnia level. Each question can be scored between 0-3. 0=not bothered at all slightly bothered moderately bothered severely bothered Total score is calculated by adding up all questions (i.e. Q1+Q2+...Q20). One missing item is allowed, pro-rate if missing one item....i.e. (sum/count)\*20. Minimum Score = 0 (good); Maximum Score = 60 (bad). Data are presented as a raw score point change.
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
n=1 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=13 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score
|
24 score on a scale
Standard Deviation 0
|
16.23 score on a scale
Standard Deviation 13.92
|
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: EEG data were not collected.
For the first and last stimulation session, EEG recording will be made before (resting-state EEG) and during (TMS-evoked potentials) the stimulation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Blood samples were not collected.
Blood (plasma) samples will be collected before and one month after stimulation. Blood collection is conducted by the registered hospital phlebotomist (following same protocol of a routine blood test). Blood samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, samples will be used for DNA/RNA extraction and analyses will be done to determine potential gene targets. Presence of inflammatory markers (cytokines) will also be determined. All analyses of blood samples will be conducted in the Open Medicine Institute.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Stool samples were not collected.
Stool samples will be collected before and one month after stimulation. Stool collection is performed by registered hospital nurses. Stool samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, stool samples will be analyzed for potential biomarkers in the gut microbiome. All analyses of stool samples will be conducted in the Open Medicine Institute.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Salvia samples were not collected.
Saliva samples will be collected before and one month after stimulation. Saliva collection is performed by registered study personnel. Saliva samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, saliva samples will be analyzed for cortisol levels. All analyses of stool samples will be conducted in the Open Medicine Institute.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Only participants who completed this questionnaire were included in this analysis.
15-item self-report questionnaire where each item is scored from very poor=1 to very good=5. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand-alone items. The raw total score ranges from 14 (min) to 70 (max).
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
n=1 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=11 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score
|
5 score on a scale
Standard Deviation 0
|
12.36 score on a scale
Standard Deviation 13.41
|
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: NIH toolbox data was not collected.
Neurocognitive assessments delivered through an iPad app
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: Participants who completed this questionnaire were included in the analysis. Participants who do not have this data completed were excluded.
Immediate Mood Scaler (IMS) is a newly developed, iPad-deliverable 12-item self-report tool designed to capture current mood states with overall score, and depression and anxiety subscales. Individual item scores range from 1-7, with a total overall score range from 12-84. Data are presented as a raw score point change in depression subscale score. The depression subscale scores range from 7-49 (higher score indicating worse depression).
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
n=1 Participants
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=15 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score
|
-6 score on a scale
Standard Deviation 0
|
11 score on a scale
Standard Deviation 12.67
|
SECONDARY outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)Population: The device used to collect pilot HRV data was only acquired after the ACC participants had been run. Only participants with collected HRV data were included in the analysis.
Measure presence of any change in heart rate variability. Data is reported as a ratio of low frequency (LF) and high frequency (HF) (LF/HF FFT). FFT: fast Fourier transform.
Outcome measures
| Measure |
Anterior Cingulate Cortex (ACC)
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
|
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=3 Participants
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
|
|---|---|---|
|
Change in Heart Rate Variability
|
—
|
-1.88 LF/HF FFT ratio
Standard Deviation 3.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of drug abuse this self-report questionnaire will be used to monitor craving of their particular drug of abuse.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of borderline personality disorder this self-report questionnaire will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of drug abuse this self-report questionnaire will be used.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of drug abuse their reported average weekly substance use will be recorded.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of an eating disorder, this self-report questionnaire will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of Anxiety, this self-report scale will be used to monitor anxiety symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of an eating disorder, this clinician-rated assessment will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of an impulse disorder, this self-report questionnaire will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of OCD, this self-report questionnaire will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of OCD, this clinician-rated scale will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of a pain disorder, this rating scale will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment, after each day of stimulation and immediate post-treatmentAfter all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of a panic disorder, this rating scale will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of PTSD, this self-report questionnaire will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of Schizophrenia, this assessment will be used to monitor symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After all stimulation sessions have been completed (approximately 48 hours after the final session)If participants have a co-morbid diagnosis of Schizophrenia, this clinician-rated assessment will be used to monitor symptoms.
Outcome measures
Outcome data not reported
Adverse Events
Dorsolateral Prefrontal Cortex (L-DLPFC)
Anterior Cingulate Cortex (ACC)
Serious adverse events
| Measure |
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=20 participants at risk
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Accelerated theta burst stimulation: All participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC (if participants do not respond to L-DLPFC stimulation, they may be offered stimulation at the ACC). Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.
|
Anterior Cingulate Cortex (ACC)
n=2 participants at risk
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC)
Accelerated theta burst stimulation: All participants will receive iTBS (intermittent theta burst stimulation) to the ACC. Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.
|
|---|---|---|
|
Psychiatric disorders
Self-harm
|
5.0%
1/20 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
0.00%
0/2 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
Other adverse events
| Measure |
Dorsolateral Prefrontal Cortex (L-DLPFC)
n=20 participants at risk
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Accelerated theta burst stimulation: All participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC (if participants do not respond to L-DLPFC stimulation, they may be offered stimulation at the ACC). Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.
|
Anterior Cingulate Cortex (ACC)
n=2 participants at risk
The accelerated theta burst stimulation protocol will be applied to the anterior cingulate cortex (ACC)
Accelerated theta burst stimulation: All participants will receive iTBS (intermittent theta burst stimulation) to the ACC. Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
2/20 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
50.0%
1/2 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
|
General disorders
Fatigue
|
20.0%
4/20 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
0.00%
0/2 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
|
Nervous system disorders
Anxiety
|
0.00%
0/20 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
50.0%
1/2 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
|
General disorders
Pain during stimulation
|
5.0%
1/20 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
50.0%
1/2 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
|
General disorders
Toothache
|
5.0%
1/20 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
0.00%
0/2 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
5.0%
1/20 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
0.00%
0/2 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
|
General disorders
Redness on forehead
|
5.0%
1/20 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
|
0.00%
0/2 • The day after treatment was completed, the participant was asked to complete a questionnaire regarding any adverse events during the week. (If any adverse events were evident to the researcher during the treatment week, a note was made and this was included in the final assessment to prevent under reporting of side-effects if the participant forgot about these events by the end of the 5 day treatment).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place