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Machine Learning Neurofeedback for PTSD

NCT03482466 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-06-28

Study results available
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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.

Conditions

  • Post-traumatic Stress Disorder

Interventions

BEHAVIORAL

Neurofeedback

Patients will be inside an MRI machine. They will be trained using real time feedback from brain imaging to learn personal strategies to bring their brain to the CALM state.

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Ramiro Salas, PhD · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-08-14
Completion
2020-11-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482466 on ClinicalTrials.gov