Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Sep 2023
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2023
CompletedFirst Posted
Study publicly available on registry
January 12, 2023
CompletedStudy Start
First participant enrolled
September 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 1, 2026
April 1, 2026
3.8 years
January 4, 2023
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Rating Scale for Depression
change over 8 weeks
Secondary Outcomes (16)
Patient Health Questionnaire-9
change over 8 weeks
Neurobehavioral Symptom Inventory
change over 8 weeks
PTSD Checklist for DSM-5
change over 8 weeks
Headache Impact Test
change over 8 weeks
Pittsburgh Sleep Quality Index
change over 8 weeks
- +11 more secondary outcomes
Study Arms (2)
PACT+iTBS
EXPERIMENTALPersonalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)
PACT+sham iTBS
SHAM COMPARATORPersonalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)
Interventions
6 sessions of PACT
Eligibility Criteria
You may qualify if:
- Male or female
- All racial and ethnic groups
- Ages 18 to 65
- Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health
- 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
- Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI
- Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
- Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
- No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
- No contraindications to MRI (passes MRI safety screening questionnaire)
- Able to commit to the treatment schedule
- Able to complete assessment procedures in English
- Intact decision-making capacity and ability to provide voluntary informed consent
You may not qualify if:
- History of moderate, severe, or penetrating TBI
- 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
- 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
- Active manic or psychotic illness per MINI
- Current substance use disorder per MINI
- Current active suicidal or homicidal ideation
- Pregnant or intending to become pregnant within the study period; breastfeeding
- Other sensory conditions or illnesses precluding participation in assessments or treatment
- Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy
- Taking medication that lowers seizure threshold
- Previous failed treatment with rTMS, iTBS, or ECT
- Completed \>4 sessions of cognitive rehabilitation within the last 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSD
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Twamley, PhD
UC San Diego
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
January 4, 2023
First Posted
January 12, 2023
Study Start
September 19, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Following study completion; deidentified data available indefinitely.
- Access Criteria
- Via FITBIR request.
IPD will be available via FITBIR.