Trial Outcomes & Findings for Real-time fMRI and Neurofeedback of Brain Networks Mediating Trauma Memory Recall in PTSD (NCT NCT02500719)
NCT ID: NCT02500719
Last Updated: 2021-08-20
Results Overview
Support vector machine decodings of functional MRI data acquired during volitional engagement or disengagement of emotional arousal. Each decoding represents the Euclidean distance and direction (either positive or negative) of the functional MRI data volume with respect to the patient's support vector machine decision hyperplane. Positive distances denote engagement of emotional arousal and negative distances denote disengagement of emotion arousal. Distance represents the magnitude of volitional engagement or disengagement. Decodings can either be provided to patients as real-time neurofeedback (via visual representation of the distance) or hidden from view. When hidden, the visual representation of neurofeedback remains stationary.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Real-time within the measurement of functional MRI (within 10 seconds of functional MRI volume acquisition and reconstruction)
Results posted on
2021-08-20
Participant Flow
Participant milestones
| Measure |
Healthy Participants
A group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal.
Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
|
PTSD Participants
A group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks.
Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Healthy Participants
A group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal.
Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
|
PTSD Participants
A group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks.
Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Trauma history
|
1
|
0
|
|
Overall Study
MRI data found to be unusable during analysis
|
0
|
1
|
|
Overall Study
Did not meet criteria for PTSD
|
0
|
1
|
|
Overall Study
Claustrophobia
|
0
|
1
|
|
Overall Study
History of head trauma
|
0
|
1
|
Baseline Characteristics
Screen failure: Trauma history reported and subject age not recorded.
Baseline characteristics by cohort
| Measure |
Healthy Participants
n=14 Participants
A group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal.
Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
|
PTSD Participants
n=16 Participants
A group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks.
Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.23 years
STANDARD_DEVIATION 8.30 • n=13 Participants • Screen failure: Trauma history reported and subject age not recorded.
|
32.5 years
STANDARD_DEVIATION 9.63 • n=16 Participants • Screen failure: Trauma history reported and subject age not recorded.
|
31.93 years
STANDARD_DEVIATION 8.92 • n=29 Participants • Screen failure: Trauma history reported and subject age not recorded.
|
|
Sex: Female, Male
Female
|
14 Participants
n=14 Participants
|
16 Participants
n=16 Participants
|
30 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=14 Participants
|
15 Participants
n=16 Participants
|
29 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
3 Participants
n=16 Participants
|
5 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=14 Participants
|
12 Participants
n=16 Participants
|
24 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
16 participants
n=16 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Real-time within the measurement of functional MRI (within 10 seconds of functional MRI volume acquisition and reconstruction)Population: Completing subjects.
Support vector machine decodings of functional MRI data acquired during volitional engagement or disengagement of emotional arousal. Each decoding represents the Euclidean distance and direction (either positive or negative) of the functional MRI data volume with respect to the patient's support vector machine decision hyperplane. Positive distances denote engagement of emotional arousal and negative distances denote disengagement of emotion arousal. Distance represents the magnitude of volitional engagement or disengagement. Decodings can either be provided to patients as real-time neurofeedback (via visual representation of the distance) or hidden from view. When hidden, the visual representation of neurofeedback remains stationary.
Outcome measures
| Measure |
Healthy Participants
n=875 Decodings
A group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal.
Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
|
PTSD Participants
n=800 Decodings
A group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks.
Computational Model - Real-time Support Vector Machine: A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory. The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
|
|---|---|---|
|
Patient Emotional Response to Volitional Engagement and Disengagement of Emotional Arousal as Measured Using Support Vector Machine Decodings When the Decoding is Provided as Real-time Neurofeedback Guidance or Not.
Volitional Engagement of Arousal Achieved without Real-time Neurofeedback Guidance.
|
-.2104 Standard score (decodings)
Standard Deviation .7311
|
.4659 Standard score (decodings)
Standard Deviation 1.194
|
|
Patient Emotional Response to Volitional Engagement and Disengagement of Emotional Arousal as Measured Using Support Vector Machine Decodings When the Decoding is Provided as Real-time Neurofeedback Guidance or Not.
Volitional Disengagement of Arousal Achieved without Real-time Neurofeedback Guidance.
|
-.2952 Standard score (decodings)
Standard Deviation .8211
|
.0080 Standard score (decodings)
Standard Deviation .9234
|
|
Patient Emotional Response to Volitional Engagement and Disengagement of Emotional Arousal as Measured Using Support Vector Machine Decodings When the Decoding is Provided as Real-time Neurofeedback Guidance or Not.
Volitional Engagement of Arousal Achieved with Real-time Neurofeedback Guidance.
|
-.0257 Standard score (decodings)
Standard Deviation .7762
|
.5244 Standard score (decodings)
Standard Deviation 1.319
|
|
Patient Emotional Response to Volitional Engagement and Disengagement of Emotional Arousal as Measured Using Support Vector Machine Decodings When the Decoding is Provided as Real-time Neurofeedback Guidance or Not.
Volitional Disengagement of Arousal Achieved with Real-time Neurofeedback Guidance.
|
-.3186 Standard score (decodings)
Standard Deviation .8262
|
-.0654 Standard score (decodings)
Standard Deviation .9453
|
Adverse Events
Healthy Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PTSD Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Keith A. Bush
University of Arkansas for Medical Sciences
Phone: 501.526.8347
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place