NCT02849223

Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to assess the magnitude of transcranial direct current stimulation (tDCS) -induced cognitive and functional change in patients with mild traumatic brain injury. This study will also attempt to identify biomarkers associated with treatment response. Last, acceptability and tolerability of procedures will be assessed. To accomplish these aims, a randomized, double-blind, sham-controlled, parallel groups, pilot study will be conducted in which participants are assigned to 24 sessions of tDCS or sham stimulation offered concurrent with working memory training. Neural efficiency will be measured with electroencephalogram (EEG) pre and post-intervention.

Detailed description

Transcranial direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that shows promise as an intervention technique. The primary aim of this study is to assess the magnitude of tDCS-induced cognitive and functional change in patients with mild traumatic brain injury (TBI). In this double-blind, sham-controlled, pilot study, 24 veterans with mild TBI will be randomized to tDCS or sham conditions. Stimulation will be administered with a StarStim neurostimulator at 2 milliamps (mA) for 20 minutes. The anodal electrode will be placed over the left dorsal lateral prefrontal cortex. Twenty-four sessions of stimulation will be administered concurrent with 20 minutes of working memory training. Participants will continue with an additional 40 minutes of working memory training post-stimulation. Participant experience with neuromodulation will be assessed with a self-report questionnaire that lists common reactions to tDCS. Participant perception of the value of neuromodulation procedures will be assessed at weeks 4 and 8. A second aim is to identify biomarkers of treatment response. Resting state electroencephalogram (EEG) will be collected at three time points: prior to the first tDCS training session, immediately after the first training session, and post-intervention. This study will provide preliminary evidence of the efficacy of providing tDCS as an intervention to enhance cognitive and functional outcomes for individuals with mild traumatic brain injury. Furthermore, the results of this study will also increase the understanding of the mechanisms by which tDCS enhances cognitive performance. This knowledge has the potential to provide insight into the underlying therapeutic process as well as to guide development of the next generation of interventions. In addition, acceptability of the intervention will be monitored to identify potential barriers to administering tDCS in clinical practice.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Anodal Transcranial Direct Current Stimulation	2 milliamps (mA) of anodal stimulation will be applied to the left dorsal lateral cortex for 20 minutes concurrent with working memory training.
DEVICE	Sham stimulation	30 seconds of anodal TDCS stimulation will be applied to the left dorsal lateral cortex concurrent with working memory training

Timeline

• Start date: 2016-07-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2016-07-29
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States