Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Not Applicable

Recruiting

• Conditions: Concussion, Brain; Depression; Mild Traumatic Brain Injury
• Interventions: Device: iTBS; Device: sham iTBS; Behavioral: Personalized, Augmented Cognitive Training (PACT)

• Registration Number: NCT05682677
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-12
• Study Start: 2023-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PACT+iTBS	Personalized, Augmented Cognitive Training (PACT)	Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)
PACT+iTBS	iTBS	Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)
PACT+sham iTBS	Personalized, Augmented Cognitive Training (PACT)	Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)
PACT+sham iTBS	sham iTBS	Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression	change over 8 weeks

Secondary Outcome Measures

Name	Time	Method
WHO Disability Assessment Schedule	change over 8 weeks
Glasgow Outcome Scale - Extended	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
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.
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
Hopkins Verbal Learning Test - Revised	change over 8 weeks
WAIS-IV Processing Speed	change over 8 weeks
PROMIS Cognitive Function Abilities Short Form	change over 8 weeks
WMS-IV Digit Span	change over 8 weeks

Trial Locations

Locations (1)

UCSD; 🇺🇸 La Jolla, California, United States