Health TrialsbyHealthPanel

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

ConditionsDepressionMild Traumatic Brain InjuryConcussion, Brain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • iTBS

    Device

    iTBS over the left dorsolateral prefrontal cortex

  • sham iTBS

    Device

    sham iTBS over the left dorsolateral prefrontal cortex

  • Personalized, Augmented Cognitive Training (PACT)

    Behavioral

    6 sessions of PACT

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: PACT+iTBSExperimental treatment 2 interventions
Group B: PACT+sham iTBSSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Hamilton Rating Scale for Depression

Time frame
change over 8 weeks

Secondary outcomes

1

Patient Health Questionnaire-9

Time frame
change over 8 weeks
2

Neurobehavioral Symptom Inventory

Time frame
change over 8 weeks
3

PTSD Checklist for DSM-5

Time frame
change over 8 weeks
4

Headache Impact Test

Time frame
change over 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

San Diego Veterans Healthcare System

Collaborator

Source ClinicalTrials.gov
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