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Trial record 4 of 101 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

Neurofeedback for PTSD (NEUROFEEDPTSD)

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ClinicalTrials.gov Identifier: NCT03482466
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Behavioral: Neurofeedback Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Virtual World/Neurofeedback Real Time Functional MRI Approach to PTSD Treatment
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : July 25, 2019
Estimated Study Completion Date : February 28, 2020

Arm Intervention/treatment
Experimental: PTSD patients
12 PTSD patients will be recruited to undergo neurofeedback training .
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.
Other Name: Real time fMRI virtual reality training




Primary Outcome Measures :
  1. CAPS5 PTSD criteria [ Time Frame: Change from baseline at 6 weeks ]

    Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to:

    Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week

    In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization).

    The CAPS was designed to be administered by clinicians and clinical researchers who have a working knowledge of PTSD, but can also be administered by appropriately trained paraprofessionals. The full interview takes 45-60 minutes to administer.



Secondary Outcome Measures :
  1. Wearable device data: heart rate [ Time Frame: Change from baseline at 6 weeks ]
    The investigators will collect heart rate data from wearable devices. It will be used to study any possible correlations between wearable device results and changes in CAPS5 during the training, regardless of whether the changes in CAPS5 are due to the training or not. Heart rate will be measured over time in beats per minute.

  2. Wearable device data: sleep patterns [ Time Frame: Change from baseline at 6 weeks ]
    The investigators will collect sleep pattern data from wearable devices. It will be used to study any possible correlations between wearable device results and changes in CAPS5 during the training, regardless of whether the changes in CAPS5 are due to the training or not. Sleep patterns will be measured over time in number of wake events per night.

  3. Wearable device data: total sleep [ Time Frame: Change from baseline at 6 weeks ]
    The investigators will collect total sleep data from wearable devices. It will be used to study any possible correlations between wearable device results and changes in CAPS5 during the training, regardless of whether the changes in CAPS5 are due to the training or not. Total sleep will be measured over time in minutes of sleep per day.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482466


Contacts
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Contact: Ramiro Salas, PhD (713) 794-7032 rsalas@bcm.edu
Contact: Wright Williams, PhD (713) 794-7629 Wright.Williams@va.gov

Locations
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United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Ramiro Salas, PhD    713-794-7032    rsalas@bcm.edu   
Principal Investigator: Ramiro Salas, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Baylor College of Medicine
Investigators
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Principal Investigator: Ramiro Salas, PhD Michael E. DeBakey VA Medical Center, Houston, TX

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03482466     History of Changes
Other Study ID Numbers: D2588-P
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders