Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Train Your Brain Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03858933
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Jeremy Goldbach, University of Southern California

Brief Summary:
The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. The other half will receive the newly developed limbic modulation index neurofeedback.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Device: eBrainFit Platform Not Applicable

Detailed Description:

Traumatic stress is commonly resistant to existing therapeutics, possibly due to high treatment dropout rates along with a failure to target the relevant underlying neural mechanisms. Neuromodulation of deep limbic areas such as the amygdala may play a critical role in the effective recovery from traumatic stress. Human studies have shown the importance of such modulation during the encoding of traumatic stimuli, showing greater amygdala activation for subsequently remembered traumatic stimuli. In addition, a prospective study among previously healthy soldiers showed that hyper-activation of the amygdala prior to military traumatic exposure corresponded with more severe post-traumatic symptoms following exposure.

Together these finding points to the amygdala as a plausible neuromodulation target for preventive or early interventions of post-traumatic disturbances. Local neuromodulation of the amygdala could improve treatment specificity and the overall intervention outcome.

The main goal of the suggested research is to further develop and implement a non-invasive, portable and cost-effective brain-imaging tool that will provide individual on-line guidance for amygdala modulation. This closed-loop brain training will enhance individual resilience to and coping with potentially traumatic stress as well as alleviate consequential psychopathologies.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The eBrainFit Platform is set to randomize each entered Subject Identification Number into either the alpha/theta or limbic modulation treatment arms. Neither the participant nor researcher will know the arm, to which the participant has been assigned.
Primary Purpose: Treatment
Official Title: Train Your Brain: A Neurofeedback Intervention for Individuals With Post-Traumatic Stress Disorder
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Limbic Modulation Index Neurofeedback

This arm of the study will undergo a novel neurofeedback treatment, targeting downregulation of deep limbic structures, specifically the amygdalae.

Participants in this arm will complete 15 neurofeedback sessions.

Device: eBrainFit Platform
Amygdala regulation with eyes open

Active Comparator: Alpha/Theta Neurofeedback

This arm of the study will undergo a proven PTSD neurofeedback treatment, alpha/theta regulation, during which participants will try various mental strategies to increase the presence of theta waves.

Participants in this arm will complete 15 neurofeedback sessions.

Device: eBrainFit Platform
Alpha/Theta regulation with eyes open




Primary Outcome Measures :
  1. Change from baseline PTSD severity using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5 [ Time Frame: administered at Initial Appointment (Week 0) and one week after the 15th neurofeedback session (approximately Week 22). ]

    The five-point CAPS-5 symptom severity rating scale is used for all symptoms. Rating scale anchors should be interpreted and used as follows:

    0 Absent The respondent denied the problem or the respondent's report doesn't fit the DSM-5 symptom criterion.

    1. Mild / subthreshold:
    2. Moderate / threshold:
    3. Severe / markedly elevated:
    4. Extreme / incapacitating:

    CAPS-5 total symptom severity score is calculated by summing severity scores for items 1-20.

    CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms contained in a given DSM-5 cluster.



Secondary Outcome Measures :
  1. Emotion Regulation Questionnaire [ Time Frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22) ]

    A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

    Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet. Items 2, 4, 6, 9 make up the Expressive Suppression facet. Scoring is kept continuous. Each facet's scoring is kept separate.


  2. Beck Depression Inventory [ Time Frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22) ]

    Quantifies depressive symptoms using a 21-item measure.

    Depression severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.


  3. Beck Anxiety Inventory [ Time Frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22) ]

    Quantifies anxious symptoms using a 21-item measure

    Anxiety severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.


  4. PTSD Checklist for DSM-5 [ Time Frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22) ]

    Quantifies PTSD symptoms using a 20-item measure

    PTSD severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.


  5. Sleep Duration [ Time Frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22) ]

    Captured using a Fitbit Physical Activity Tracking Device

    The device will report the participant's sleep duration (output in minutes) for each night the device is worn.


  6. Emotional Stroop Task [ Time Frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22) ]

    Behavioral metric of conflict adaptation.

    Emotion regulation will be assessed using a well-established emotional conflict paradigm that arises from an incompatibility between the task-relevant and task-irrelevant emotional dimensions of a stimulus and allows for the tracking of emotion regulation from trial to trial. In this task there is less conflict, indexed by faster reaction times for incongruent trials, than if they are preceded by a congruent trial. This difference in reaction times between low conflict resolution and high conflict resolution trials serves as a behavioral metric of conflict adaptation. A negative adaptation score reflects activation of a regulatory mechanism that leads to improved emotional conflict resolution.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous diagnosis of PTSD
  • PTSD symptoms within the last 30 days

Exclusion Criteria:

  • Any active psychosis or suicidal intent
  • A severe traumatic brain injury (one in which consciousness was lost for greater than 6 hours)
  • Any of the following neurological disorders: Parkinson's, Alzheimer's, Brain Tumor, or Brain Lesion.

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): NCT03858933


Contacts
Layout table for location contacts
Contact: Garrett Weskamp 4242614968 vetnfb@usc.edu

Locations
Layout table for location information
United States, California
University Of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Garrett Weskamp    424-261-4968    vetnfb@usc.edu   
Sponsors and Collaborators
University of Southern California
Tel Aviv University
Investigators
Layout table for investigator information
Principal Investigator: Jeremy Goldbach, PhD Faculty Professor
  Study Documents (Full-Text)

Documents provided by Jeremy Goldbach, University of Southern California:
Informed Consent Form  [PDF] October 30, 2018


Additional Information:
Layout table for additonal information
Responsible Party: Jeremy Goldbach, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03858933     History of Changes
Other Study ID Numbers: UP-16-00399-AM011
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeremy Goldbach, University of Southern California:
PTSD
Post-Traumatic Stress Disorder
Acute Stress Syndrome
Emotion Regulation
Depression
Anxiety
Sexual Assault
Combat PTSD

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