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Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether personalized thinking-skills training plus iTBS, a type of magnetic brain stimulation, helps depression after a mild traumatic brain injury (TBI). It is for service members, veterans, and civilians with mild TBI and depression. Everyone gets thinking-skills training plus 20 sessions of real or sham (inactive) brain stimulation over 4 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 65, of any sex, race, or ethnic group.
  • A military service member getting care at NMCSD or a civilian getting care at UCSD Health.
  • Had a mild TBI more than 3 months before joining, based on the study’s injury review.
  • Have a current episode of major depression confirmed by an interview, with a depression test score of at least 18.
  • Psychiatric medicines have stayed the same for 6 weeks, with no changes expected during the study.
  • Pass safety checks for magnetic brain stimulation (TMS) and an MRI scan.
  • Can attend treatment visits and complete study tests in English.
  • Can make your own decisions and freely agree to join.

Who can't join

  • Have had a moderate or severe TBI, or an injury that pierced the skull.
  • Have another brain or nerve condition, such as stroke, dementia, epilepsy, or past brain surgery. Most past seizures also rule you out, except seizures caused by ECT treatment or fever in infancy.
  • Have an implanted medical device, such as a pacemaker or medicine pump, or metal in or near the head, outside the mouth, that cannot be safely removed.
  • Have current mania (extreme high mood or energy), psychosis (trouble knowing what is real), a substance use disorder, or active thoughts of suicide or killing someone.
  • Are pregnant, plan to become pregnant during the study, or are breastfeeding.
  • Have a problem with your senses or another illness that prevents you from doing study tests or treatment.
  • Take at least 2 mg of lorazepam daily, a matching dose of a similar drug, any anti-seizure medicine, or medicine that raises seizure risk.
  • Previously tried rTMS, iTBS, or ECT brain stimulation without success, or had more than 4 thinking-skills rehabilitation sessions in the past 3 years.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA