Recruiting
Phase 2
Phase 3

eTMS

Sponsor:

Marcia Bockbrader, MD PhD

Code:

NCT05835414

Conditions

Trauma and Stressor Related Disorders

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)

Study Details

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.

Conditions

Trauma and Stressor Related Disorders

Study ID

NCT05835414

Start date

Apr 10, 2023

Status verified date

May, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adjunctive eTMS treatment (no delay)

6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment

Interventions

Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)

Approximately 2000 pulses per session (x30 sessions) of midline prefrontal, repetitive transcranial magnetic stimulation at 50% or less of motor threshold, calibrated via EEG to a resonant alpha frequency of the participant, and given over approximately 12 minutes. Given as an adjunct to standard of care and integrative treatment for TSRD.

Primary outcome measure

  • Number of participants with device-related serious adverse events [ Time Frame: 6 weeks ]
  • Rate of participants completing 80% of scheduled visits [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Marcia A Bockbrader, MD, PhD

614-670-4000dr.marcie@bepmedicalgroup.com

Neil B Austin

614-670-4000neil@bepmedicalgroup.com

Locations

BEP Medical Group LLC

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Practice Manager

614-670-4000admin@bepmedicalgroup.com

Principal Investigator:

Marcia A Bockbrader, MD, PhD

More Information

Sponsor

Marcia Bockbrader, MD PhD

Last update posted

May 6, 2023

Last verified

May, 2023

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marcia Bockbrader, MD PhD on 2023-05-06.