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rTMS for TBI-related Depression (ADEPT Trial)

N/A
Waitlist Available
Led By David L Brody, MD, PhD
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up period, from 1-6 months after the final rtms session
Awards & highlights

Summary

This trial will compare three types of rTMS to see which is most effective in treating depression in military service members with a history of concussion.

Who is the study for?
This trial is for U.S. military service members or veterans aged 18-50 with a history of concussion/mild TBI and depression. They must have stable medication and therapy regimens, be able to consent in English, and have experienced specific short-term memory or consciousness changes due to TBI.
What is being tested?
The study tests the effectiveness of two types of rTMS treatments on alleviating depression symptoms in individuals with a history of mild TBI. Participants will receive either actual rTMS or sham (placebo) treatment targeting the DLPFC area of the brain.
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, seizures (very rare), or temporary hearing changes due to the noise during treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up period, from 1-6 months after the final rtms session
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up period, from 1-6 months after the final rtms session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mental Depression
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores in a Subgroup
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores from Baseline to 6-month follow-up
+3 more
Secondary study objectives
Comparison of Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR) Scores from Baseline to 6-month follow-up
Comparison of Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR) Scores from Baseline to post-intervention
Comparison of Change in PTSD Checklist for DSM-5 (PCL-5) Scores from Baseline to 6-month Follow-up
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 2Experimental Treatment1 Intervention
Active rTMS/resting state functional MRI (rsfMRI)-based targeting
Group II: Arm 1Experimental Treatment1 Intervention
Active rTMS/Individualized Connectome Targeting (ICT)
Group III: Arm 3Placebo Group2 Interventions
Sham rTMS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Congressionally Directed Medical Research ProgramsFED
54 Previous Clinical Trials
9,413 Total Patients Enrolled
Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
96 Previous Clinical Trials
93,017 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
122 Previous Clinical Trials
90,346 Total Patients Enrolled
~132 spots leftby Sep 2026
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