Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Recruiting · NCT05682677 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Diego
View the official record on ClinicalTrials.gov →Interventions studied
Personalized, Augmented Cognitive Training (PACT)iTBSsham iTBS
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 (as defined by the DoD/VA criteria used in conjunction with the OSU TBI-ID method) over 3 months prior to study entry
- Meets criteria for current Major Depressive Episode within the context of 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 changes to psychiatric medications expected during the study period
- No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
- No contraindications to MRI (passes MRI safety screening questionnaire)
- Able to commit to the treatment schedule
- Able to complete assessment procedures in English
- Intact decision-making capacity and ability to provide voluntary informed consent
Exclusion criteria
- History of moderate, severe, or penetrating TBI
- History of other neurological condition unrelated to TBI, including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy
- Implanted medical devices including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed
- Active manic or psychotic illness per MINI
- Current substance use disorder per MINI
- Current active suicidal or homicidal ideation
- Pregnant or intending to become pregnant within the study period; breastfeeding
- Other sensory conditions or illnesses precluding participation in assessments or treatment
- Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy
- Taking medication that lowers seizure threshold
- Previous failed treatment with rTMS, iTBS, or ECT
- Completed \>4 sessions of cognitive rehabilitation within the last 3 years
Where it is running
1 location listed across 1 US state.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →