Trials / Completed

CompletedNCT04925453

tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study

Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Improve Concentration and Working Memory in Active Duty Service Members Following Mild Traumatic Brain Injury (mTBI): A Pilot Study

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 56 (actual)

Sponsor: United States Naval Medical Center, San Diego · Federal
Sex: All
Age: 18 Years – 55 Years
Healthy volunteers: Not accepted

Summary

The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.

Detailed description

Objectives: The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mTBI. Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms. Research Plan and Methods: This is a double-blind, randomized, placebo (sham) controlled pilot study. We will recruit 60 Active Duty Service Members who are receiving outpatient services at Naval Medical Center San Diego, with a history of mTBI and reported neurocognitive symptoms related to attention, working memory, and related cognitive processes. Intake will involve a full pre-assessment of symptoms, neurocognitive performance, and an optional MRI scan. Participants will be randomized to either active or sham tDCS. Training/tDCS sessions will occur daily over five consecutive days. Random permuted blocks will be used to ensure exactly equal treatment numbers at certain equally spaced points in the sequence of patient assignment. Post-intervention assessment will include another assessment of symptoms, neurocognitive performance, and an optional MRI scan. Participants will complete assessments of symptoms and neurocognitive performance six-weeks following the post-intervention assessment. Clinical Relevance to TBICoE/Navy Medicine: Aspects of this study will provide insight into a major research gap highlighted in the mission of the Defense and Veterans Brain Injury Center, specifically in identifying/ developing innovative treatments/interventions which promote patient recovery and/or mitigate symptoms after mTBI. Novel, well-tolerated, neuroplasticity-based interventions that can improve attention, concentration, and working memory by targeting the underlying neural dysfunction are needed to improve outcomes and quality of life for Active Duty Service Members affected by neurocognitive weakness and dysfunction following mTBI. If tDCS proves successful in reducing TBI-related symptoms, improving cognition, or enhancing functional recovery, this non-invasive intervention could be implemented within various DoD and VA settings, enhancing recovery, improving quality of life, and bolstering occupational performance.

Conditions

Interventions

Type	Name	Description
COMBINATION_PRODUCT	active tDCS and cognitive training intervention	Intervention sessions will occur during Visits 2-6. Cognitive training will occur concurrently with tDCS in both the active and sham tDCS groups. Over each 46-minute daily training period, 4 of 5 BrainHQ training tasks will be performed for approximately 11 minutes in a randomly selected order. Order of task presentation will be randomized each session. Stimulation sequences will occur in the first 13 minutes (shut off: Minute 13) of the session and the last 13 minutes of the session (turn on: Minute 33). The Symptom Rating Questionnaire (SRQ) will be asked before and after stimulation to assess for any side-effects. The BrainHQ Task Load Index (TLX) will be administered at the end of each intervention session. At the end of Intervention Session 3, subjects will be given a Blinding Questionnaire which asks whether they thought they received active or sham treatment.
COMBINATION_PRODUCT	sham tDCS and cognitive training intervention	Intervention sessions will occur during Visits 2-6. Cognitive training will occur concurrently with tDCS in both the active and sham tDCS groups. Over each 46-minute daily training period, 4 of 5 BrainHQ training tasks will be performed for approximately 11 minutes in a randomly selected order. Order of task presentation will be randomized each session. Stimulation sequences will occur in the first and last 13 minutes of the session. For sham stimulation, the electrodes will be placed at the same positions as for active stimulation, but current will be ramped down immediately after the initial 30s ramp up period. The Symptom Rating Questionnaire (SRQ) will be asked before and after stimulation to assess for any side-effects. The BrainHQ Task Load Index (TLX) will be administered at the end of each intervention session. At the end of Intervention Session 3, subjects will be given a Blinding Questionnaire which asks whether they thought they received active or sham treatment.

Timeline

Start date: 2021-01-19
Primary completion: 2025-06-30
Completion: 2025-07-30
First posted: 2021-06-14
Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04925453. Inclusion in this directory is not an endorsement.