NCT05682677

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

• Depression
• Mild Traumatic Brain Injury
• Concussion, Brain

Interventions

Type	Name	Description
DEVICE	iTBS	iTBS over the left dorsolateral prefrontal cortex
DEVICE	sham iTBS	sham iTBS over the left dorsolateral prefrontal cortex
BEHAVIORAL	Personalized, Augmented Cognitive Training (PACT)	6 sessions of PACT

Timeline

• Start date: 2023-09-19
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-01-12
• Last updated: 2024-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study