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Recruiting NCT05682677

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

No phase Interventional Depression Mild Traumatic Brain Injury Concussion, Brain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iTBS, sham iTBS, Personalized, Augmented Cognitive Training (PACT).
Who it may be relevant to
Registry conditions: Depression, Mild Traumatic Brain Injury, Concussion, Brain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

  • Hamilton Rating Scale for Depression [Time frame: change over 8 weeks]
Secondary outcome measures (12)
  • Patient Health Questionnaire-9 [Time frame: change over 8 weeks]
  • Neurobehavioral Symptom Inventory [Time frame: change over 8 weeks]
  • PTSD Checklist for DSM-5 [Time frame: change over 8 weeks]
  • Headache Impact Test [Time frame: change over 8 weeks]
  • Pittsburgh Sleep Quality Index [Time frame: change over 8 weeks]
  • WHO Disability Assessment Schedule [Time frame: change over 8 weeks]
  • Glasgow Outcome Scale - Extended [Time frame: change over 8 weeks]
  • PROMIS Cognitive Function Abilities Short Form [Time frame: change over 8 weeks]
  • Patient Global Impression of Change [Time frame: rating at 8 weeks]
  • Traumatic Brain Injury Quality of Life [Time frame: change over 8 weeks]
  • D-KEFS Trail Making Test [Time frame: change over 8 weeks]
  • D-KEFS Color Word Interference Test [Time frame: change over 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCSD — La Jolla

Identifiers

NCT: NCT05682677 · W81XWH-22-2-0045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗