Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Jan 11, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help treat depression in individuals who have experienced a mild traumatic brain injury (TBI), such as a concussion. The study will test a combination of two treatments: Personalized Augmented Cognitive Training (PACT) and a specific type of brain stimulation called intermittent theta burst stimulation (iTBS). Participants will either receive the PACT plus iTBS or PACT plus a fake treatment (sham iTBS) over four weeks. Researchers want to see if those receiving the real treatment show more improvement in their depression symptoms compared to those receiving the sham treatment.

To participate in the trial, individuals must be between 18 and 65 years old and have a history of mild TBI along with moderate to severe depression. They should also be stable on their current psychiatric medications. Participants will be evaluated at the beginning of the study, then at two, four, and eight weeks after starting treatment. It’s important for anyone interested in joining the study to be able to commit to attending all sessions and completing assessments in English. This trial is currently recruiting participants, so it’s a great opportunity for those who meet the criteria and are seeking help for their depression after a mild TBI.

Gender

ALL

Eligibility 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