Recruiting

Neuromodulation & Cognitive Training

Sponsor:

UCLA

Code:

NCT05682677

Conditions

Depression

Mild Traumatic Brain Injury

Concussion, Brain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

iTBS

sham iTBS

Personalized, Augmented Cognitive Training (PACT)

Study Details

Brief 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

Study ID

NCT05682677

Start date

Sep 19, 2023

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

iTBS

iTBS over the left dorsolateral prefrontal cortex

sham iTBS

sham iTBS over the left dorsolateral prefrontal cortex

Personalized, Augmented Cognitive Training (PACT)

6 sessions of PACT

Primary outcome measure

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

Central Contacts and Locations

Locations

UCSD

Recruiting

La Jolla, California, United States, 92093

Contacts

More Information

Sponsor

University of California, San Diego

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • brain stimulation
  • neuromodulation
  • transcranial magnetic stimulation
  • theta burst stimulation
  • TMS
  • TBS
  • rTMS
  • iTBS
  • cognitive training
  • cognitive rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-05-01.