Trial Outcomes & Findings for Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder (NCT NCT03574974)
NCT ID: NCT03574974
Last Updated: 2024-02-15
Results Overview
Control over the amygdala will be defined as the change in the blood-oxygen-level dependent (BOLD) signal in the target area (an individually-localized region of interest (ROI) in the amygdala) during down-regulation blocks following symptom provocation relative to rest. Investigators will assess the magnitude of change in control over the amygdala to trauma reminders from baseline to 30-day post treatment follow-up. This measure is based on beta values, which are unitless
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
baseline; 30 day-day follow up
Results posted on
2024-02-15
Participant Flow
Participant milestones
| Measure |
Experimental Feedback Intervention
Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.
Experimental Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators believe that this feedback may help participants learn to control their PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
Control Feedback Intervention
Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.
Control Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators do not believe this feedback can help participants' PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
12
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Experimental Feedback Intervention
n=14 Participants
Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.
Experimental Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators believe that this feedback may help participants learn to control their PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
Control Feedback Intervention
n=11 Participants
Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.
Control Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators do not believe this feedback can help participants' PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
40.2 years
STANDARD_DEVIATION 14.27 • n=99 Participants
|
50.36 years
STANDARD_DEVIATION 12.78 • n=107 Participants
|
44.67 years
STANDARD_DEVIATION 14.31 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
11 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Medication Status
No psychiatric medication
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Medication Status
Antidepressants
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Medication Status
Anticonvulsant
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Medication Status
Stimulants
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Medication Status
Medical Marijuana/Cannabinoids (CBD Oil)
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Medication Status
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, (CAPS-5
|
33.71 score
STANDARD_DEVIATION 7.99 • n=99 Participants
|
39.73 score
STANDARD_DEVIATION 9.27 • n=107 Participants
|
36.36 score
STANDARD_DEVIATION 8.93 • n=206 Participants
|
|
PTSD Checklist for DSM-5 (PCL-5)
|
43.43 score
STANDARD_DEVIATION 13.42 • n=99 Participants
|
47.45 score
STANDARD_DEVIATION 14.03 • n=107 Participants
|
45.20 score
STANDARD_DEVIATION 13.555 • n=206 Participants
|
|
Additional Diagnoses
Major Depressive Disorder(MDD)
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Additional Diagnoses
MDD in partial remission
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Additional Diagnoses
MDD in full remission
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Additional Diagnoses
Dysthymic Disorder
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Additional Diagnoses
Obsessive-Compulsive Disorder
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Additional Diagnoses
Social Phobia
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Additional Diagnoses
Generalized Anxiety Disorder
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Additional Diagnoses
Body Dysmorphic Disorder
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Additional Diagnoses
Panic Disorder with Agoraphobia
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Additional Diagnoses
Panic Disorder without Agoraphobia
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Additional Diagnoses
Agoraphobia without History of Panic Disorder
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Additional Diagnoses
Phobia of Heights
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Additional Diagnoses
Stratification: high re-experiencing (vs low)
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline; 30 day-day follow upControl over the amygdala will be defined as the change in the blood-oxygen-level dependent (BOLD) signal in the target area (an individually-localized region of interest (ROI) in the amygdala) during down-regulation blocks following symptom provocation relative to rest. Investigators will assess the magnitude of change in control over the amygdala to trauma reminders from baseline to 30-day post treatment follow-up. This measure is based on beta values, which are unitless
Outcome measures
| Measure |
Experimental Feedback Intervention
n=14 Participants
Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.
Experimental Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators believe that this feedback may help participants learn to control their PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
Control Feedback Intervention
n=11 Participants
Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.
Control Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators do not believe this feedback can help participants' PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
|---|---|---|
|
Change in Control Over the Amygdala
|
-0.279 unitless
Standard Error 0.146
|
0.202 unitless
Standard Error 0.167
|
SECONDARY outcome
Timeframe: Baseline; 30-day follow-upClinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) \[CAPS-5\]). Score ranges from 0 - no PTSD symptoms to a maximum of 80. Higher score is associated with increase severity of PTSD. A change in CAPS score of more than 5 points over the course of treatment is considered a meaningful change and a change of 10 point or more is considered to be a clinically meaningful change.
Outcome measures
| Measure |
Experimental Feedback Intervention
n=14 Participants
Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.
Experimental Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators believe that this feedback may help participants learn to control their PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
Control Feedback Intervention
n=11 Participants
Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.
Control Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators do not believe this feedback can help participants' PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
|---|---|---|
|
Improvements in PTSD Symptoms
|
8.786 Average CAPS change score
Standard Deviation 9.744
|
10.545 Average CAPS change score
Standard Deviation 13.441
|
SECONDARY outcome
Timeframe: Baseline; 60-day follow-upClinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) \[CAPS-5\]). Score ranges from 0 - no PTSD symptoms to a maximum of 80. Higher score is associated with increase severity of PTSD. A change in CAPS score of more than 5 points over the course of treatment is considered a meaningful change and a change of 10 point or more is considered to be a clinically meaningful change.
Outcome measures
| Measure |
Experimental Feedback Intervention
n=14 Participants
Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.
Experimental Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators believe that this feedback may help participants learn to control their PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
Control Feedback Intervention
n=11 Participants
Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.
Control Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators do not believe this feedback can help participants' PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
|---|---|---|
|
Improvements in PTSD Symptoms
|
13.286 Average change in CAPS scores
Standard Deviation 9.934
|
9.364 Average change in CAPS scores
Standard Deviation 13.246
|
SECONDARY outcome
Timeframe: Baseline; 60 days follow up.Population: Due to the COVID-19 suspension of human subject research, resting state date for 60-day post treatment were not available for 4 participants in the experiential group and 1 subject in the control group.
The number of participants with a significant whole brain change in seed region connectivity to the amygdala from pre- to post-intervention will be assessed in the blood-oxygen-level dependent (BOLD) signal collected during resting state runs.
Outcome measures
| Measure |
Experimental Feedback Intervention
n=10 Participants
Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.
Experimental Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators believe that this feedback may help participants learn to control their PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
Control Feedback Intervention
n=10 Participants
Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.
Control Feedback: Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators do not believe this feedback can help participants' PTSD symptoms.
Participants will attend a total of 18 feedback scans over the course of 3 sessions.
|
|---|---|---|
|
Number of Participants With Changes in Resting State Connectivity to the Amygdala
|
0 number of participants with change
|
0 number of participants with change
|
Adverse Events
Experimental Feedback Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Feedback Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place