Concussion, Brain, Depression, Mild Traumatic Brain Injury
Conditions
Keywords
brain stimulation, neuromodulation, transcranial magnetic stimulation, theta burst stimulation, TMS, TBS, rTMS, iTBS, cognitive training, cognitive rehabilitation
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.
Interventions
DEVICEiTBS
iTBS over the left dorsolateral prefrontal cortex
DEVICEsham iTBS
sham iTBS over the left dorsolateral prefrontal cortex
BEHAVIORALPersonalized, Augmented Cognitive Training (PACT)
6 sessions of PACT
Sponsors
University of California, San Diego
San Diego Veterans Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression | change over 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| WHO Disability Assessment Schedule | change over 8 weeks | — |
| Glasgow Outcome Scale - Extended | change over 8 weeks | — |
| PROMIS Cognitive Function Abilities Short Form | change over 8 weeks | — |
| Patient Global Impression of Change | rating at 8 weeks | This measure asks the participant to rate their status since the start of the study from 1 (very much improved) to 7 (very much worse) |
| Traumatic Brain Injury Quality of Life | change over 8 weeks | The Traumatic Brain Injury Quality of Life The Traumatic Brain Injury Quality of Life measurement system (TBI-QOL) is a TBI-specific extension of the NIH PROMIS and Neuro-QoL measures that includes 20 items measuring physical, emotional, social, and cognitive domains |
| D-KEFS Trail Making Test | change over 8 weeks | — |
| D-KEFS Color Word Interference Test | change over 8 weeks | — |
| WMS-IV Digit Span | change over 8 weeks | — |
| WAIS-IV Processing Speed | change over 8 weeks | — |
| Hopkins Verbal Learning Test - Revised | change over 8 weeks | — |
| UCSD Performance-Based Skills Assessment-Brief | change over 8 weeks | The UCSD Performance-Based Skills Assessment-Brief is a performance-based measure that uses role play scenarios to assess capacity for financial and communication tasks. |
Countries
United States
Contacts
CONTACTMichelle Schy
CONTACTJanae Wyckoff
PRINCIPAL_INVESTIGATORElizabeth Twamley, PhD
UC San Diego
Outcome results
None listed