RecruitingNot ApplicableNCT05682677

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Sponsor

University of California, San Diego

Enrollment

72 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

Depression Mild Traumatic Brain Injury Concussion, Brain

Summary

The primary goal of this clinical trial is to evaluate whether Personalized Augmented Cognitive Training (PACT) plus intermittent theta burst stimulation (iTBS) is effective for treating depression in Service Members, Veterans, and civilians who have sustained a mild TBI. Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments — brain stimulation (using a non-invasive technique called TMS) and cognitive training exercises — for military service members and civilians experiencing depression after a mild traumatic brain injury (mTBI or concussion). **You may be eligible if...** - You are between 18 and 65 years old - You have a history of mild TBI (concussion) that occurred more than 3 months ago - You currently meet criteria for major depressive disorder - Your depression symptoms are moderate to severe (HAMD-17 score of 18 or higher) - You have been on stable psychiatric medications for at least 6 weeks - You have no contraindications to brain MRI or TMS (magnetic stimulation) **You may NOT be eligible if...** - You have had a moderate, severe, or penetrating brain injury - You have epilepsy, brain surgery, a pacemaker, or metal implants near the head - You have active mania, psychosis, or suicidal thoughts - You are currently using high-dose benzodiazepines or anticonvulsant medications - You have previously failed treatment with TMS or ECT - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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