Actively Recruiting
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Led by University of California, San Diego · Updated on 2026-05-01
72
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
S
San Diego Veterans Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- All racial and ethnic groups
- Ages 18 to 65
- Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health
- History of mild TBI over 3 months prior to study entry as defined by DoD/VA criteria and OSU TBI-ID method
- Meets criteria for current Major Depressive Episode within Major Depressive Disorder per MINI
- Score of 18 or higher on the HAMD-17 indicating moderate to severe depressive symptoms
- Stable on psychiatric medications for 6 weeks with no expected changes during the study
- No contraindications to TMS (passes TMS Adult Safety Screening questionnaire)
- No contraindications to MRI (passes MRI safety screening questionnaire)
- Able to commit to treatment schedule
- Able to complete assessments in English
- Intact decision-making capacity and able to provide voluntary informed consent
You will not qualify if you...
- History of moderate, severe, or penetrating TBI
- History of neurological conditions unrelated to TBI including increased intracranial pressure, brain lesions, cerebral aneurysm, stroke, transient ischemic attack within 2 years, Parkinson's disease, Huntington's disease, dementia, multiple sclerosis, brain surgery, epilepsy except ECT-induced or febrile seizures of infancy
- Implanted medical devices or metal objects near the head that cannot be safely removed
- Active manic or psychotic illness per MINI
- Current substance use disorder per MINI
- Current active suicidal or homicidal thoughts
- Pregnant, intending to become pregnant during the study, or breastfeeding
- Sensory conditions or illnesses preventing participation
- Current lorazepam dose 2 mg or greater daily or equivalent benzodiazepine or any anticonvulsant
- Taking medication that lowers seizure threshold
- Previous failed treatment with rTMS, iTBS, or ECT
- Completed more than 4 sessions of cognitive rehabilitation within the last 3 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UCSD
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
M
Michelle Schy
CONTACT
J
Janae Wyckoff
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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