Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild TBI

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Active-Duty Service Members.

• Ages 18 to 60.

• All genders.

• All racial and ethnic groups.

• History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months and no more than 10 years prior to enrollment.

• Self-reported attention and/or concentration difficulties.

• At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale.

Locations
United States
California
Naval Medical Center San Diego
RECRUITING
San Diego
Minnesota
Minneapolis VA Health Case System
RECRUITING
Minneapolis
Contact Information
Primary
Lars D Hungerford, PhD
lars.d.hungerford.ctr@health.mil
619.532.5715
Backup
Sean M Molnar, M.A.
sean.m.molnar2.ctr@health.mil
424.341.8860
Time Frame
Start Date: 2024-07-25
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 160
Treatments
Experimental: Active tDCS
Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation. Stimulation will be applied for 20 minutes at the beginning of each session. Current will be ramped from 0 mA to 2 mA over 30 seconds, and then ramped down from 2 mA to 0 mA at the end of 20 minutes. Current will be applied via two electrodes consisting of a pre-inserted carbon rubber snap electrode that is pre-saturated with saline and connects directly to designated electrode sites located on the tDCS headband. The anodal stimulating electrode will be at location F3 (based on the 10-20 EEG location system) and the cathodal electrode at location F4.
Sham_comparator: Sham tDCS
Electrodes will be placed at the same positions as for active stimulation (F3 and F4), but current will be ramped down immediately after the initial 30s ramp up period and then at 20 minutes ramped up and down as done at the beginning. Thus, participants feel the initial tingling sensation associated with tDCS, but will receive no active current for the rest of the stimulation period
Sponsors
Leads: United States Naval Medical Center, San Diego
Collaborators: United States Department of Defense, Center for Veterans Research and Education, The Defense and Veterans Brain Injury Center, Minneapolis Veterans Affairs Medical Center, University of Minnesota, General Dynamics Information Technology

This content was sourced from clinicaltrials.gov