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
N/A
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
Researchers are evaluating whether combining Personalized Augmented Cognitive Training (PACT) with intermittent theta burst stimulation (iTBS) can help treat depression in adults who have experienced a mild traumatic brain injury (mTBI). This study involves Service Members, Veterans, and civilians and aims to compare the effects of PACT plus iTBS against PACT plus a sham (placebo) iTBS treatment. The goal is to see if the active combination leads to greater improvements in depression over an 8-week period. Participants receive six sessions of PACT over four weeks and twenty sessions of either real iTBS or sham iTBS applied to the left dorsolateral prefrontal cortex during the same time frame. The study groups are randomized, and both participants and researchers are blinded to which treatment is given. The study uses a device to deliver iTBS, and the sham group receives a simulated version to help measure the treatment effect. During the study, participants undergo assessments at the start, two weeks, four weeks, and eight weeks. These include depression rating scales, questionnaires on symptoms like PTSD and headaches, cognitive function tests, and quality of life measures. Safety screenings for MRI and TMS compatibility are conducted, and participants must be able to follow the treatment schedule and complete all procedures in English. The main outcome is the change in depression severity after 8 weeks, tracked using the Hamilton Rating Scale for Depression.
CONDITIONS
Brief 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 with OSU TBI-ID method
- Meets criteria for current Major Depressive Episode within Major Depressive Disorder per MINI
- Score of 18 or higher on the Hamilton Depression Rating Scale (HAMD-17)
- Stable on psychiatric medications for 6 weeks with no expected changes during 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 informed consent
You will not qualify if you...
- History of moderate, severe, or penetrating TBI
- Other neurological conditions unrelated to TBI including increased intracranial pressure, brain lesions, aneurysm, stroke, TIA in past 2 years, Parkinson's, Huntington's, dementia, multiple sclerosis, brain surgery, epilepsy (except ECT-induced or febrile seizure in infancy)
- Implanted medical devices near head that cannot be removed safely (e.g., pacemaker, pump, aneurysm clip, shunt, stimulator, cochlear implant)
- Active manic or psychotic illness per MINI
- Current substance use disorder per MINI
- Active suicidal or homicidal thoughts
- Pregnant, intending pregnancy during study, or breastfeeding
- Sensory conditions or illnesses preventing participation in assessments or treatment
- Current dose of lorazepam 2 mg or greater daily 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 in last 3 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive Personalized, Augmented Cognitive Training (PACT) with 6 sessions over 4 weeks combined with either active or sham intermittent theta burst stimulation (iTBS) with 20 sessions over 4 weeks.
Multiple visits for cognitive training and neuromodulation sessions over 4 weeks
Duration - Up to 8 weeks
Participants are monitored for changes in depression and related symptoms for a total of 8 weeks from start of treatment.
1 visit at 8 weeks post-treatment
Trial Site Locations
Total: 1 location
1
UCSD
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
M
Michelle Schy
J
Janae Wyckoff
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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