NCT05835414

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Marcia Bockbrader, MD PhD · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2023-04-28
• Last updated: 2023-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study