Clinical trial NCT05682677: Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Official title: Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Mild Traumatic Brain Injury
Concussion, Brain
Keywords: brain stimulation
neuromodulation
transcranial magnetic stimulation
theta burst stimulation
TMS
TBS
rTMS
iTBS
cognitive training
cognitive rehabilitation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego Veterans Healthcare System
First posted: 2023-01-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: change over 8 weeks
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: change over 8 weeks
measure: Neurobehavioral Symptom Inventory
timeFrame: change over 8 weeks
measure: PTSD Checklist for DSM-5
timeFrame: change over 8 weeks
measure: Headache Impact Test
timeFrame: change over 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: change over 8 weeks
measure: WHO Disability Assessment Schedule
timeFrame: change over 8 weeks
measure: Glasgow Outcome Scale - Extended
timeFrame: change over 8 weeks
measure: PROMIS Cognitive Function Abilities Short Form
timeFrame: change over 8 weeks
measure: Patient Global Impression of Change
timeFrame: rating at 8 weeks
measure: Traumatic Brain Injury Quality of Life
timeFrame: change over 8 weeks
measure: D-KEFS Trail Making Test
timeFrame: change over 8 weeks
measure: D-KEFS Color Word Interference Test
timeFrame: change over 8 weeks
measure: WMS-IV Digit Span
timeFrame: change over 8 weeks
measure: WAIS-IV Processing Speed
timeFrame: change over 8 weeks
measure: Hopkins Verbal Learning Test - Revised
timeFrame: change over 8 weeks
measure: UCSD Performance-Based Skills Assessment-Brief
timeFrame: change over 8 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
affiliation: UC San Diego
name: Elizabeth Twamley, PhD
role: PRINCIPAL_INVESTIGATOR
References: