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eTMS for Stress-Related Disorders (ETMS4Stress Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Marcia Bockbrader, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess the safety, feasibility and efficacy of eTMS for veterans with chronic TSRD.

Who is the study for?
This trial is for US military veterans with chronic trauma and stressor-related disorders who have experienced deployment-related stressful events. They must be enrolled in addiction or opioid reduction services if applicable, agree to limit alcohol intake, and not exceed a certain daily dose of opioids. Those with uncontrolled medical conditions, active untreated addictions (except cannabis), or contraindications to TMS like metal implants are excluded.
What is being tested?
The study tests the safety and effectiveness of EEG-enhanced transcranial magnetic stimulation (eTMS) as an additional treatment alongside standard care for veterans' chronic trauma disorders. It involves 30 sessions of eTMS over several weeks, with regular reassessments and follow-ups extending up to 36 weeks post-enrollment.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures. However, since this trial aims to assess safety among other factors, all possible side effects will be closely monitored throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with device-related serious adverse events
Rate of participants completing 80% of scheduled visits
Secondary study objectives
Mean change in Veterans RAND 36-item health survey (VR-36) mental component scores (MCS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adjunctive eTMS treatment (no delay)Experimental Treatment1 Intervention
6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment

Find a Location

Who is running the clinical trial?

Ohio Department of Mental Health and Addiction ServicesUNKNOWN
Marcia Bockbrader, MD PhDLead Sponsor

Media Library

Adjunctive eTMS treatment (no delay) Clinical Trial Eligibility Overview. Trial Name: NCT05835414 — Phase 2 & 3
Trauma and Stressor Related Disorders Research Study Groups: Adjunctive eTMS treatment (no delay)
Trauma and Stressor Related Disorders Clinical Trial 2023: Adjunctive eTMS treatment (no delay) Highlights & Side Effects. Trial Name: NCT05835414 — Phase 2 & 3
Adjunctive eTMS treatment (no delay) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05835414 — Phase 2 & 3
~11 spots leftby Dec 2025
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