Combining brain stimulation and cognitive training to treat depression after mild brain injuries
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
This study is testing if combining brain stimulation with special cognitive training can help people with depression after a mild brain injury feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT05682677 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of Personalized Augmented Cognitive Training (PACT) combined with intermittent theta burst stimulation (iTBS) in treating depression among Service Members, Veterans, and civilians who have experienced a mild traumatic brain injury (TBI). Participants will undergo 20 sessions of either iTBS or sham stimulation over a four-week period, alongside PACT. Evaluations will be conducted at baseline, 2 weeks, 4 weeks, and 8 weeks to compare the outcomes between the two groups and determine if the combination therapy leads to greater improvements in depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with a history of mild TBI and current major depressive episodes.
Not a fit: Patients who do not meet the eligibility criteria, such as those with contraindications to TMS or MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment options for individuals suffering from depression following mild TBIs.
How similar studies have performed: Other studies have shown promise in using neuromodulation techniques for treating depression, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female 2. All racial and ethnic groups 3. Ages 18 to 65 4. Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health 5. 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 6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI 7. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms 8. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period 9. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire) 10. No contraindications to MRI (passes MRI safety screening questionnaire) 11. Able to commit to the treatment schedule 12. Able to complete assessment procedures in English 13. Intact decision-making capacity and ability to provide voluntary informed consent Exclusion Criteria: 1. History of moderate, severe, or penetrating TBI 2. 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 3. 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 4. Active manic or psychotic illness per MINI 5. Current substance use disorder per MINI 6. Current active suicidal or homicidal ideation 7. Pregnant or intending to become pregnant within the study period; breastfeeding 8. Other sensory conditions or illnesses precluding participation in assessments or treatment 9. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy 10. Taking medication that lowers seizure threshold 11. Previous failed treatment with rTMS, iTBS, or ECT 12. Completed \>4 sessions of cognitive rehabilitation within the last 3 years
Where this trial is running
La Jolla, California
- UCSD — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Twamley, PhD — UC San Diego
- Study coordinator: Michelle Schy
- Email: mschy@health.ucsd.edu
- Phone: 858-642-3848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.