Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder (PTSD)

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: NCT03574974
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Yale University

Brief Summary:

The primary purpose of this study is to investigate the efficacy of neurofeedback (NF) of real-time functional magnetic resonance imaging (rt-fMRI) data of the amygdala with regards to the reduction of post-traumatic stress disorder (PTSD) symptoms.

A secondary purpose of this study is to use fMRI as a method of investigating brain function in individuals with PTSD. This study approach provides a tool for probing the neurobiology of PTSD by (1) testing the critical role of the amygdala in this disorder, and by (2) examining how amygdala connectivity is related to both amygdala regulation and clinical symptoms.


Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Device: Experimental Feedback Device: Control Feedback Not Applicable

Detailed Description:

In pursuit of the overarching goals of this study, the investigators aim to:

  • determine if an experimental feedback intervention increases control over the region of interest (the amygdala) more than a control feedback intervention in which participants receive feedback that is unassociated with their PTSD symptoms.
  • determine if an experimental feedback intervention results in clinical improvements in PTSD symptoms relative to a control feedback intervention, and examine whether these improvements correlate with improved control over the amygdala.
  • determine if an experimental feedback intervention results in changes in resting state connectivity to the amygdala, and whether these changes correlate with symptom improvement and an improved ability to regulate the amygdala.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will receive either an experimental feedback intervention or a control feedback intervention. Participants who receive the control feedback intervention will be offered to return to receive the experimental feedback intervention upon completion of the study.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be blind to group assignment (experimental feedback intervention or control feedback intervention). The outcome assessor will be blind to group assignment.
Primary Purpose: Treatment
Official Title: Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder (PTSD)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Feedback Intervention
Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.
Device: Experimental Feedback

Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators believe that this feedback may help participants learn to control their PTSD symptoms.

Participants will attend a total of 18 feedback scans over the course of 3 sessions.


Placebo Comparator: Control Feedback Intervention
Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.
Device: Control Feedback

Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators do not believe this feedback can help participants' PTSD symptoms.

Participants will attend a total of 18 feedback scans over the course of 3 sessions.





Primary Outcome Measures :
  1. Control over the amygdala: baseline [ Time Frame: 1/2 week before intervention ]
    Control over the amygdala will be defined as the percent signal change in the blood-oxygen-level dependent (BOLD) signal in the target area (an individually-localized region of interest [ROI] in the amygdala) during symptom provocation relative to down-regulation blocks.

  2. Control over the amygdala: follow-up [ Time Frame: 1/2 week after intervention ]
    Control over the amygdala will be defined as the percent signal change in the blood-oxygen-level dependent (BOLD) signal in the target area (an individually-localized region of interest [ROI] in the amygdala) during symptom provocation relative to down-regulation blocks.


Secondary Outcome Measures :
  1. Improvements in PTSD symptoms: baseline [ Time Frame: ≤1 month before intervention ]
    Clinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) [CAPS-5]). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19 = asymptomatic/few symptoms, 20-39 = sub-threshold/mild PTSD, 40-59 = threshold/moderate PTSD, 60-79 = severe PTSD, >80 = extreme PTSD.

  2. Improvements in PTSD symptoms: follow-up 1 [ Time Frame: 1 month after intervention ]
    Clinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) [CAPS-5]). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19 = asymptomatic/few symptoms, 20-39 = sub-threshold/mild PTSD, 40-59 = threshold/moderate PTSD, 60-79 = severe PTSD, >80 = extreme PTSD.

  3. Improvements in PTSD symptoms: follow-up 2 [ Time Frame: 2 months after intervention ]
    Clinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) [CAPS-5]). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19 = asymptomatic/few symptoms, 20-39 = sub-threshold/mild PTSD, 40-59 = threshold/moderate PTSD, 60-79 = severe PTSD, >80 = extreme PTSD.

  4. Changes in resting state connectivity to the amygdala: baseline [ Time Frame: 1/2 week before intervention ]
    Whole brain changes in seed region connectivity to the amygdala from pre- to post-intervention will be assessed in the blood-oxygen-level dependent (BOLD) signal collected during resting state runs.

  5. Changes in resting state connectivity to the amygdala: follow-up [ Time Frame: 1/2 week after intervention ]
    Whole brain changes in seed region connectivity to the amygdala from pre- to post-intervention will be assessed in the blood-oxygen-level dependent (BOLD) signal collected during resting state runs.



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Ages 18 and up
  • Diagnosis of chronic PTSD, as established by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V; CAPS-5)
  • Ability to give signed, informed consent in English
  • Normal or corrected-to-normal vision
  • Participants who are on a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressants for 2 months (3 months if they are on sertraline), or who have been un-medicated for at least 2 months, will be allowed to participate in this study
  • At the time of recruitment, patients must have no intention of changing their medication or psychotherapy during the 2.5-month period of the intervention
  • Research group must be able to identify a trauma-related target region in or immediately adjacent to the amygdala

Exclusion Criteria

  • Any primary psychiatric diagnosis of a current major mood disorder, psychotic disorder, autism, mental retardation, or DSM-5 substance use disorder of mild or greater severity (2 or more symptoms) in the past 30 days. Comorbid mood and anxiety disorders will be permitted if they are not the primary focus of clinical attention
  • Any history of psychosis or mania
  • Active suicidality within past year, or history of suicide attempt in past 2 years
  • Any contraindication to MRI scanning (severe claustrophobia, ferromagnetic metal in body, etc.)
  • Pregnancy
  • Any unstable medical or neurological condition
  • Any history of severe past drug dependence (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
  • Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury [TBI] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days)
  • Significant hearing loss or severe sensory impairment
  • Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs)
  • Any change in accepted psychotropic medication within the past 2 months
  • Active engagement in cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy [CPT], Prolonged Exposure [PE], Eye Movement Desensitization and Reprocessing [EMDR]) initiated within the past 3 months; continuation of established maintenance supportive therapy will be permitted
  • Enrollment in another research study testing an experimental/clinical/behavioral intervention intended to affect symptoms initiated within the last 2 months, or intended enrollment within the next 2.5 months

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): NCT03574974


Contacts
Layout table for location contacts
Contact: Charles Gordon, MA (203) 937-4760 charles.gordon@yale.edu
Contact: William Koller (203) 737-6055 ptsdnfrecruitment@yale.edu

Locations
Layout table for location information
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: William Koller    203-737-6055    ptsdnfrecruitment@yale.edu   
Principal Investigator: Michelle Hampson, PhD         
VA Connecticut Healthcare System - West Haven Campus Recruiting
West Haven, Connecticut, United States, 06516
Contact: Charles Gordon, MA    203-937-4760    charles.gordon@yale.edu   
Principal Investigator: Ilan Harpaz-Rotem, PhD         
Sponsors and Collaborators
Yale University
VA Connecticut Healthcare System
Investigators
Layout table for investigator information
Principal Investigator: Ilan Harpaz-Rotem, PhD Yale University School of Medicine, VA
Principal Investigator: Michelle Hampson, PhD Yale University

Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03574974     History of Changes
Other Study ID Numbers: 2000022668
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

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 Yale University:
PTSD
Neurofeedback

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