Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder

NCT03574974 | Terminated Results DMC

• 2 other identifiers: 20000226681R61MH115110-01A1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD; Neurofeedback

Outcome Measures

Primary Outcomes (1)

• Change in Control Over the Amygdala

  Control over the amygdala will be defined as the change in the blood-oxygen-level dependent (BOLD) signal in the target area (an individually-localized region of interest (ROI) in the amygdala) during down-regulation blocks following symptom provocation relative to rest. Investigators will assess the magnitude of change in control over the amygdala to trauma reminders from baseline to 30-day post treatment follow-up. This measure is based on beta values, which are unitless

  baseline; 30 day-day follow up

Secondary Outcomes (3)

• Improvements in PTSD Symptoms

  Baseline; 30-day follow-up

• Improvements in PTSD Symptoms

  Baseline; 60-day follow-up

• Number of Participants With Changes in Resting State Connectivity to the Amygdala

  Baseline; 60 days follow up.

Study Arms (2)

Experimental Feedback Intervention

EXPERIMENTAL

Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.

Device: Experimental Feedback

Control Feedback Intervention

PLACEBO COMPARATOR

Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.

Device: Control Feedback

Interventions

Experimental Feedback DEVICE

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.

Experimental Feedback Intervention

Control Feedback DEVICE

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.

Control Feedback Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• VA Connecticut Healthcare System: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

VA Connecticut Healthcare System - West Haven Campus

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ilan Harpaz-Rotem Professor
• Organization: Yale University

ilan.harpaz-rotem@yale.edu

203-937-4760

Study Officials

• Ilan Harpaz-Rotem, PhD

  Yale University School of Medicine, VA

  PRINCIPAL INVESTIGATOR

• Michelle Hampson, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blind to group assignment (experimental feedback intervention or control feedback intervention). The outcome assessor will be blind to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: July 2, 2018
• Study Start: June 1, 2018
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: February 15, 2024
• Results First Posted: October 18, 2023

Record last verified: 2024-02

Locations

US (2)