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NCT05835414: ETMS4Stress

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

Status unknown Phase 2, PHASE3 Last updated 6 May 2023
What this trial tests

Phase 2, PHASE3 trial testing Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS) in Trauma and Stressor Related Disorders in 30 participants. Status unknown.

Timeline
10 April 2023
Primary endpoint
30 June 2024
30 June 2025

Quick facts

Lead sponsorMarcia Bockbrader, MD PhD
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date10 April 2023
Primary completion30 June 2024
Estimated completion30 June 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Marcia Bockbrader, MD PhD

Who can join

22 and older, any sex, with Trauma and Stressor Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing