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

Primary Purpose

Post-Traumatic Stress Disorder

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Experimental Feedback

Control Feedback

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Neurofeedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale School of Medicine
VA Connecticut Healthcare System - West Haven Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Feedback Intervention

Control Feedback Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvements in PTSD Symptoms

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]). Score ranges from 0 - no PTSD symptoms to a maximum of 80. Higher score is associated with increase severity of PTSD. A change in CAPS score of more than 5 points over the course of treatment is considered a meaningful change and a change of 10 point or more is considered to be a clinically meaningful change.

Improvements in PTSD Symptoms

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

The number of participants with a significant whole brain change 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.

Full Information

NCT ID

NCT03574974

First Posted

June 7, 2018

Last Updated

September 26, 2023

Sponsor

Yale University

Collaborators

VA Connecticut Healthcare System, National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT03574974

Brief Title

Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder

Acronym

PTSD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Terminated

Why Stopped

Funding ended prematurely

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

March 8, 2022 (Actual)

Study Completion Date

March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

VA Connecticut Healthcare System, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorder

Keywords

PTSD, Neurofeedback

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Feedback Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Control Feedback Intervention

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Experimental Feedback

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Control Feedback

Intervention Description

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 Measure Information:

Title

Change in Control Over the Amygdala

Description

Time Frame

baseline; 30 day-day follow up

Secondary Outcome Measure Information:

Title

Improvements in PTSD Symptoms

Description

Time Frame

Baseline; 30-day follow-up

Title

Improvements in PTSD Symptoms

Description

Time Frame

Baseline; 60-day follow-up

Title

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

Description

Time Frame

Baseline; 60 days follow up.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ilan Harpaz-Rotem, PhD

Organizational Affiliation

Yale University School of Medicine, VA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michelle Hampson, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

VA Connecticut Healthcare System - West Haven Campus

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

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Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder

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