Clinical trial NCT05835414: Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD)
Official title: Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS for Stress)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Trauma and Stressor Related Disorders
Keywords: Transcranial Magnetic Stimulation
Chronic Trauma and Stressor Related Disorders
Veterans RAND 36-item health survey (VR-36)
Health Related Quality of Life
EEG
Alpha Rhythms
Lead sponsor: BEP Medical Group, LLC
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a staged, open-label, Phase II/III safety, feasibility, and efficacy investigational device trial. A staged approach will be utilized to assess safety, feasibility, and preliminary efficacy with 30 participants with an interim analysis after data collection at 6 weeks. If safety benchmarks are passed, the study will proceed with Stage 2, in which an additional 270 participants will be enrolled using randomization to multiple baselines for efficacy analyses.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with device-related serious adverse events
timeFrame: 6 weeks
measure: Rate of participants completing 80% of scheduled visits
timeFrame: 6 weeks
Secondary outcomes:
measure: Mean change in Veterans RAND 36-item health survey (VR-36) mental component scores (MCS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: BEP Medical Group LLC
state: Ohio
Study officials:
References: