Machine Learning Neurofeedback for PTSD

NCT03482466 | Terminated Results

• 1 other identifier: D2588-P
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• CAPS-5 PTSD Criteria

  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 occupational functioning, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The CAPS-5 produces reliable and valid scores with standard administration. It should be administered by qualified interviewers with formal training in structured clinical interviewing and differential diagnosis, a thorough understanding of the conceptual basis of PTSD, and detailed knowledge of the measure's features and conventions.

  6 weeks

Secondary Outcomes (3)

• Wearable Device Data: Heart Rate

  Change from baseline at 6 weeks

• Wearable Device Data: Sleep Patterns

  Change from baseline at 6 weeks

• Wearable Device Data: Total Sleep

  Change from baseline at 6 weeks

Study Arms (1)

PTSD patients

EXPERIMENTAL

12 PTSD patients will be recruited to undergo neurofeedback training .

Behavioral: Neurofeedback

Interventions

Neurofeedback BEHAVIORAL

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.

Also known as: Real time fMRI virtual reality training

PTSD patients

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet CAPS5 PTSD criteria
• OEF/OIF/OND \& PGW Veterans
• Seeking treatment for PTSD

You may not qualify if:

• DSM-5 criteria for drug or alcohol abuse or dependence in past 30 days
• History of moderate to severe traumatic brain injury
• Presence of contraindications to MRI
• Current neurological or general medical conditions known to impact cognitive and/or emotional functioning (epilepsy, Parkinson's, etc.)
• Acute psychological instability, schizophrenia, etc.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Limitations and Caveats

Due to unforeseen circumstances including COVID-19, we were unable to complete the whole project.

Results Point of Contact

• Title: Ramiro Salas
• Organization: Baylor College of Medicine; Michael E. DeBakey VA Medical Center; Menninger Clinic

rsalas@bcm.edu

7137983502

Study Officials

• Ramiro Salas, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 12 PTSD patients will be exposed to the real time functional MRI neurofeedback training. The investigators will assess PTSD symptoms both clinically and with a "take home" wearable device that will collect data on physical activity, heart rate, and sleep patterns.

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 29, 2018
• Study Start: November 1, 2018
• Primary Completion: August 14, 2020
• Study Completion: November 24, 2020
• Last Updated: June 28, 2024
• Results First Posted: June 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)