rTMS for Military TBI-related Depression

Part of paid clinical trials in Palo Alto, California.

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study ID
NCT05426967
Status
Recruiting
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Conditions

  • Concussion
  • Depressive Symptoms
  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) — DEVICE
    Active rTMS
  • Sham rTMS — DEVICE
    Sham comparator to active rTMS

Study Details

The purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion/mild traumatic brain injury (TBI).

Key Dates

Start date
Dec 16, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Active rTMS/Individualized Connectome Targeting (ICT)
  • Experimental: Arm 2
    Active rTMS/resting state functional MRI (rsfMRI)-based targeting
  • Sham Comparator: Arm 3
    Sham rTMS

Primary Outcome Measure

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores [ Time Frame: Baseline to post-intervention, within 10 working days of the final rTMS session ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care SystemPalo AltoCalifornia94304
Rachel Dieterich
[email protected]
Maheen M Adamson, PhD (PRINCIPAL_INVESTIGATOR)
William Beaumont Army Medical CenterFort BlissTexas79918
Diana Hernandez
[email protected]
(915) 248-8029
Cuong Phan, APRN, MSN, MSW, AGCNS-BC
[email protected]
(984) 325-9458
Jesse Wolfe, MD (PRINCIPAL_INVESTIGATOR)
Alexander T. Augusta Military Medical CenterFort BelvoirVirginia22060
Vanessa Donahue, BS
Zachary J Craig, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By research site
VA Palo Alto Health Care System· Palo Alto, CAWilliam Beaumont Army Medical Center· Fort Bliss, TXAlexander T. Augusta Military Medical Center· Fort Belvoir, VA

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