- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04209387
Novel EEG Coherence Biomarkers for PTSD Assessment
Neurophysiology Markers of PTSD's Presence, Severity and Therapy Outcome
Study Overview
Status
Conditions
Detailed Description
The project involves 3 types of research studies :
Study 1. This is a retrospective study where the Neuromarker analyses will be applied to a large existing database (n=656) containing sleep EEG recordings along with health and functional outcome measures, from Veterans with PTSD only (n=107), TBI only (n=126), both PTSD and TBI (n=87), depression only (n=80), and controls (no PTSD/TBI/Depression; n=256).
Study 2. This is a prospective study with n=10 Veterans with PTSD and n=10 controls to evaluate potential improvement on the performance of the Neuromarkers using a dense array (up to 64) EEG montage.
Study 3. This is a prospective study with PTSD (n=50) at multiple times during the Veterans ongoing clinical treatment for PTSD. sleep EEG measures will be collected at pretreatment, after first session of therapy, immediately after completion of therapy, and at 3-month post therapy.
Methodology:
For retrospective Study 1, the investigators will evaluate the performance of the PTSD neuromarker, in terms of sensitivity/ specificity/accuracy, utilizing a database of n=656 Veterans who have previously enrolled in the VA Portland Health Care System Sleep Laboratory Data Repository. The data repository contains sleep polysomnography (PSG) recordings (EEG and cardiorespiratory parameters), demographic information, medical history, and the following validated surveys (1) Epworth Sleepiness Scale, (2) NIH PROMIS, (3) Insomnia Severity Index, (4) Functional Outcomes of Sleep, (5) Patient Health Questionnaire, (6) PTSD symptoms checklist (PCL-5).
For prospective study 1, the investigators will perform sleep-EEG studies in n=10 PTSD and n=10 control subjects using a 64 channel EEG montage and will compare the performance of the neuromarkers, in distinguishing PTSD from non-PTSD groups, with the accuracy of diagnosis using only six EEG electrodes as performed in Study 1.
For prospective study 2, n=50 Veterans with PTSD symptoms undergoing the Veterans clinical treatment at the Bedford VA will be recruited and the following data will be acquired: Sleep-EEG, Demographic, Medical History, and Use of Medications forms, The Beck Depression Inventory, Pittsburgh Sleep Quality Index, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, NIH PROMIS, PCL-5, and Clinician-Administered PTSD Scale (CAPS-5). Primary independent variable will be changes in the Neuromarker and the dependent variables will consist of the functional and quality of life measures.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Mo Modarres, PhD
- Phone Number: (781) 687-8984
- Email: Mo.Modarres@va.gov
Study Locations
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Massachusetts
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Bedford, Massachusetts, United States, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Veterans who have been previously deployed and meet diagnostic criteria for PTSD. Prior traumatic experience(s) does not have to be direct combat (e.g. may include search and rescue of combat operations). Persons previously treated for PTSD will be eligible so long as current diagnostic criteria are present. Specific inclusion criteria are as follows:
- Current (past month) diagnosis of PTSD as determined from the 30-item CAPS (score >45).
- History of deployment and combat-related exposure stated as the principal reason for seeking treatment (based on self-report).
- Ability to read and speak English to complete surveys and participate in therapy.
- Explicit denial of suicidal or homicidal ideation or intent, which will be corroborated by reviewing the patient chart.
Exclusion Criteria:
- Brain injury prohibiting speech, writing, and purposeful actions.
- Identified to have current suicidal or homicidal ideation (immediate referral to a crisis center/hospital).
Major confounding psychiatric disorder; i.e. assessment indicates presence of:
- Major mental health disorder that involves psychosis
- Otherwise in the state of psychological crisis (appropriate referral to occur)
- Current or recent (within 1 month of study entry) DSM-5 substance use disorder
- Individuals who are taking either illicit or prescribed Rx that could interfere with EEG, including benzodiazepines and certain mood stabilizers (e.g., Lithium)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control
No PTSD, TBI, and Depression
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PTSD
Veterans with PTSD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EEG-based Neuromarker Change
Time Frame: Pre-treatment (within one week of initiation of PTSD therapy), within one week before initiation of their treatment protocol, within one week after the conclusion of their treatment phase, and about three months after their last therapy session
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Neuromarkers computed from Coherence of brain activity
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Pre-treatment (within one week of initiation of PTSD therapy), within one week before initiation of their treatment protocol, within one week after the conclusion of their treatment phase, and about three months after their last therapy session
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mo Modarres, PhD, VA Bedford HealthCare System, Bedford, MA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- D2846-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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