Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT05682677
Status
Recruiting
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Conditions

  • Concussion, Brain
  • Depression
  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 19, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PACT+iTBS
    Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)
  • Sham Comparator: PACT+sham iTBS
    Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)

Primary Outcome Measure

Hamilton Rating Scale for Depression [ Time Frame: change over 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSDLa JollaCalifornia92093
Michelle Schy
[email protected]
858-642-3848
Janae Wyckoff
[email protected]
858-642-3848

Find similar trials in La Jolla, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
UCSD· La Jolla, CA

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