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Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

NCT05682677 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-01

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Elizabeth Twamley, PhD · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05682677 on ClinicalTrials.gov