ClinicalTrials.Veeva

Menu

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

University of California San Diego logo

University of California San Diego

Status

Enrolling

Conditions

Mild Traumatic Brain Injury
Depression
Concussion, Brain

Treatments

Device: iTBS
Behavioral: Personalized, Augmented Cognitive Training (PACT)
Device: sham iTBS

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT05682677
W81XWH-22-2-0045

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Central trial contact

Michelle Schy; Janae Wyckoff

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems