Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD)

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Trauma and Stressor Related Disorders

In brief

The goal of this clinical trial is to learn about the safety, feasibility, and preliminary efficacy of EEG-enhanced transcranial magnetic stimulation (eTMS) as an adjunct to standard-of-care therapies for chronic trauma and stressor related disorders (TSRD) among US military veterans. The main questions the study aims to answer are: * Is it safe to provide 30 sessions of eTMS for veterans with chronic TSRD? * Is it feasible to provide 30 sessions of eTMS as an adjunct to standard-of-care therapies for veterans with chronic TSRD? * Does health-related quality of life improve among veterans after 30 sessions of eTMS as an adjunct to standard-of-care therapies for chronic TSRD? Participants will undergo 30 sessions of eTMS as an adjunct to standard-of-care therapies for veterans with chronic TSRD, weekly reassessment during treatment, and intermittent follow-up for 36 weeks post-enrollment.

Key facts

Study ID

NCT05835414

Run by

Marcia Bockbrader, MD PhD

People needed

30

Starts

2023-04-10

Expected to finish

2025-06-30

Last updated by the study team

2023-05-06

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Positive identification as a Veteran per discharge paperwork (DD-214, DD-215, NGB-22, NGB-22A) and photo ID, or Veterans Health Administration Veteran Health Identification Card (VHIC)
• Presence of deployment-related stressful events (as defined by the Deployment Risk \& Resilience Inventory-2, DRRI-2)
• Trauma event(s) (defined on the Life Experiences Checklist for DSM-5, LEC-5)
• Presence of 6 months or more of 6 or more "moderate" or worse symptoms from any of the five categories associated with stress disorders as operationalized on the PTSD Checklist for DSM-5 (PCL-5; intrusion, altered mood and cognitions, dissociation, avoidance, and arousal).
• Informed consent for study participation, off label-eTMS, and data use
• Enrollment in addiction services, if meets standard addiction treatment criteria
• Enrollment in opioid reduction services, if dependent on opioids and morphine equivalent daily dose exceeds 50 mg (50 morphine equivalent daily dose, MEDD)
• Agreement to limit daily alcoholic beverage consumption to no more than 2 servings
• Signed pain contract, if MEDD >= 80, per State of Ohio prescribing guidelines

You may not qualify if…

• Uncontrolled medical, psychological or neurological conditions including, but not limited to:
• Uncontrolled psychosis or mania
• Uncontrolled seizure disorder or EEG abnormalities that indicate risk of seizure, i.e., epileptiform discharges during the EEG recording
• Uncontrolled cardiac, pulmonary, or endocrine disorder (e.g., diabetes)
• Acute pain or illness
• Active, untreated addiction to prescription drugs, alcohol or illicit substances (not including cannabis or derivatives, which are available in many states under medical prescription or for recreational use)
• Clinically significant medical condition or abnormality that in the Investigator's judgment might pose a potential safety risk to the subject or limit the interpretation of the trial results
• Pregnant, or female unwilling to use effective birth control during the course of the trial (unless cleared for participation by obstetrician/gynecologist)
• Absolute contraindications to TMS: Presence of aneurysm clips or coils, cochlear or ocular implant, cortical epidural stimulator, deep brain stimulator, pacemaker or defibrillator, retained intracranial metal foreign body (bullets, shrapnel - excluding titanium and oral implants), steel stents or shunts, active vagal nerve stimulator, ventriculoperitoneal (VP) shunt.
• Prior TMS treatment
• Unwilling or unable to adhere to the study treatment, data collection schedule, or study procedures

Where it is running

• BEP Medical Group LLC — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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