Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Depression Clinical Trial

Official title:

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682677
• Other study ID #: W81XWH-22-2-0045
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: September 2023
• Source: University of California, San Diego
• Contact: Michelle Schy
• Phone: 858-642-3848
• Email: mschy[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Brain
• Depression
• Depressive Disorder
• Mild Traumatic Brain Injury

Intervention

Device:
• iTBS
iTBS over the left dorsolateral prefrontal cortex
• sham iTBS
sham iTBS over the left dorsolateral prefrontal cortex

Behavioral:
• Personalized, Augmented Cognitive Training (PACT)
6 sessions of PACT

Locations

Country	Name	City	State
United States	UCSD	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression		change over 8 weeks
Secondary	Patient Health Questionnaire-9		change over 8 weeks
Secondary	Neurobehavioral Symptom Inventory		change over 8 weeks
Secondary	PTSD Checklist for DSM-5		change over 8 weeks
Secondary	Headache Impact Test		change over 8 weeks
Secondary	Pittsburgh Sleep Quality Index		change over 8 weeks
Secondary	WHO Disability Assessment Schedule		change over 8 weeks
Secondary	Glasgow Outcome Scale - Extended		change over 8 weeks
Secondary	PROMIS Cognitive Function Abilities Short Form		change over 8 weeks
Secondary	Patient Global Impression of Change	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)	rating at 8 weeks
Secondary	Traumatic Brain Injury Quality of Life	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	change over 8 weeks
Secondary	D-KEFS Trail Making Test		change over 8 weeks
Secondary	D-KEFS Color Word Interference Test		change over 8 weeks
Secondary	WMS-IV Digit Span		change over 8 weeks
Secondary	WAIS-IV Processing Speed		change over 8 weeks
Secondary	Hopkins Verbal Learning Test - Revised		change over 8 weeks
Secondary	UCSD Performance-Based Skills Assessment-Brief	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.	change over 8 weeks