Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression Mild Traumatic Brain Injury Concussion, Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PACT+iTBS

Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)

Group Type EXPERIMENTAL

iTBS

Intervention Type DEVICE

iTBS over the left dorsolateral prefrontal cortex

Personalized, Augmented Cognitive Training (PACT)

Intervention Type BEHAVIORAL

6 sessions of PACT

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)

Group Type SHAM_COMPARATOR

sham iTBS

Intervention Type DEVICE

sham iTBS over the left dorsolateral prefrontal cortex

Personalized, Augmented Cognitive Training (PACT)

Intervention Type BEHAVIORAL

6 sessions of PACT

Interventions

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iTBS

iTBS over the left dorsolateral prefrontal cortex

Intervention Type DEVICE

sham iTBS

sham iTBS over the left dorsolateral prefrontal cortex

Intervention Type DEVICE

Personalized, Augmented Cognitive Training (PACT)

6 sessions of PACT

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No