RecruitingNot Applicable

rTMS for Military TBI-related Depression

United States198 participantsStarted 2024-12-16

Plain-language summary

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).

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Positive Loss of Consciousness of \<30 minutes as confirmed by the TBI Screener and/or medical records and/or;
✓. Positive Alteration of Consciousness of \<24 hours as confirmed by the TBI Screener and/or medical records and/or;
✓. Positive Post-traumatic Amnesia of 0 to 1 day as confirmed by the TBI Screener and/or medical records.

Exclusion criteria

✕. History of unprovoked seizures.
✕. History of seizure within 24 hours of sustaining a concussion(s) or other head injury regardless of whether it was determined to have been related to concussion.
✕. Family history of two or more unprovoked seizures in a first degree relative (parent, sibling, or child).
✕. History of Moderate, Severe, or Penetrating TBI based on TBI Screener and/or medical records.
✕. Intracranial lesion (such as intracranial tumor or intraparenchymal hemorrhage) that, in the opinion of the investigators, would increase seizure risk.
✕. Currently taking medication or other substances (such as tricyclic antidepressants or neuroleptics) that, in the opinion of the investigator, lowers the seizure threshold.

What they're measuring

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

Timeframe: Baseline to post-intervention, within 10 working days of the final rTMS session

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores in a Subgroup

Timeframe: Baseline to post-intervention, within 10 working days of the final rTMS session

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores from Baseline to 6-month follow-up

Timeframe: Baseline to 6 months

Comparison of Treatment Response or Remission in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

Timeframe: Baseline to post-intervention, within 10 working days of the final rTMS session

Comparison of Duration of Remission of Depressive Symptoms in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

Timeframe: Follow-up Period, from 1-6 months after the final rTMS session

Comparison of Frequency of Adverse Events

Timeframe: Baseline to post-intervention, within 10 working days of the final rTMS session

Trial details

NCT IDNCT05426967

SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Elizabeth N Diaz Nelson, MPH

832-671-9532 elizabeth.nelson.ctr@usuhs.edu

View on ClinicalTrials.gov More Depressive Symptoms trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Positive Loss of Consciousness of \<30 minutes as confirmed by the TBI Screener and/or medical records and/or;
✓. Positive Alteration of Consciousness of \<24 hours as confirmed by the TBI Screener and/or medical records and/or;
✓. Positive Post-traumatic Amnesia of 0 to 1 day as confirmed by the TBI Screener and/or medical records.

Exclusion criteria

✕. History of unprovoked seizures.
✕. History of seizure within 24 hours of sustaining a concussion(s) or other head injury regardless of whether it was determined to have been related to concussion.
✕. Family history of two or more unprovoked seizures in a first degree relative (parent, sibling, or child).
✕. History of Moderate, Severe, or Penetrating TBI based on TBI Screener and/or medical records.
✕. Intracranial lesion (such as intracranial tumor or intraparenchymal hemorrhage) that, in the opinion of the investigators, would increase seizure risk.
✕. Currently taking medication or other substances (such as tricyclic antidepressants or neuroleptics) that, in the opinion of the investigator, lowers the seizure threshold.

What they're measuring

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

Timeframe: Baseline to post-intervention, within 10 working days of the final rTMS session

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores in a Subgroup

Timeframe: Baseline to post-intervention, within 10 working days of the final rTMS session

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores from Baseline to 6-month follow-up

Timeframe: Baseline to 6 months

Comparison of Treatment Response or Remission in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

Timeframe: Baseline to post-intervention, within 10 working days of the final rTMS session

Comparison of Duration of Remission of Depressive Symptoms in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

Timeframe: Follow-up Period, from 1-6 months after the final rTMS session

Comparison of Frequency of Adverse Events

Timeframe: Baseline to post-intervention, within 10 working days of the final rTMS session