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NCT03482466 · ClinicalTrials.gov registry record · NA
Machine Learning Neurofeedback for PTSD
A NA study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT03482466: Clinical Trial NA study, sponsored by VA Office of Research and Development.
NCT03482466 is a NA study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03482466, a NA study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
A commonly used therapy for post-traumatic stress disorder (PTSD) that often (but not always) gives good results is "exposure therapy": When the patient (for example, Veterans who have attacks of anxiety when a noise startles them) talks about the trauma that precipitated the PTSD, she or he slowly becomes less sensitive to PTSD. This works only on some patients. The investigators propose to expose PTSD patients to a number of "training" sessions in which they will be in a virtual world (similar to a video game) driving a car through a place resembling Iraq. This will happen inside an MRI machine, and the investigators will obtain brain images while the patient is exploring the "virtual Iraq" environment. The investigators will project on the screen a bar that will let the patient know, in real time, which is the state of her or his brain, from CALM to STRESS. The job of the patient will be to try to come up with personal strategies (breathe slowly, think calming thoughts) to try to bring the bar to CALM. The investigators believe that after a number of sessions, the patient will be able to create personalized mental strategies to bring their brain to CALM state, even in real life. This could become a much stronger way of performing "exposure therapy". Finally, the investigators will use a wearable device (similar to a wristwatch) to be able to study physical activity and sleep patters in PTSD patients through the training, in the hope that the investigators may find a way to objectively study when a patient is doing better.
Primary Outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview that can be used to determine: current (past month) diagnosis of PTSD, lifetime diagnosis of PTSD, PTSD symptoms over the past week. Scores range from 0 - 80, with higher scores indicating increased PTSD symptom severity. The full interview takes 45-60 minutes to administer. In addition to PTSD symptoms, questions target symptom onset and duration, subjective distress, impact of symptoms on social and occupat
Interventions
- BEHAVIORAL Neurofeedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2020-11-24 |
| Phase | NA |
Why NCT03482466 stopped before completion
NCT03482466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Neurofeedback is the first listed.
NCT03482466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03482466 about?
NCT03482466 is a clinical study titled "Machine Learning Neurofeedback for PTSD". A commonly used therapy for post-traumatic stress disorder (PTSD) that often (but not always) gives good results is "exposure therapy": When the patient (for example, Veterans who have attacks of anxiety when a noise startles them) talks about the trauma that precipitated the PTSD, she or he slowly ...
What is the current status of trial NCT03482466?
This trial is currently terminated. It is a NA study. The enrollment target is 14 participants. The study started on 2018-11-01. Estimated completion is 2020-11-24.
What interventions are being tested in trial NCT03482466?
The interventions under investigation include: Neurofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT03482466?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03482466's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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