NCT06989970

Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Traumatic Brain Injury (TBI) often results in a wide array of cognitive impairments, which can significantly diminish quality of life for affected individuals. While traditional rehabilitation methods typically adopt a standardized approach, it's crucial to acknowledge the significant heterogeneity within the TBI patient population. Neglecting these variations reduces the likelihood of otherwise effective treatments being considered for widespread adoption. Emerging evidence highlights the potential of transcranial direct current stimulation (tDCS) as a promising adjunctive therapy. tDCS, a noninvasive and safe neuro-rehabilitative procedure, has shown efficacy when integrated with cognitive training across various neurological disorders, such as depression, post-stroke aphasia, and neurodegenerative conditions. This study aims to investigate the effectiveness of tDCS paired with behavioral therapy, particularly cognitive training, in improving cognition and executive function in chronic TBI patients. Additionally, tDCs targets in the current study will be tailored to each individual patient, recognizing the patient's unique needs and circumstances

Detailed description

Objective: This pilot study (targeting a sample of 10 TBI patients) aims to investigate whether combining cognitive training with anodal tDCS can enhance cognitive function more effectively compared to cognitive training alone in individuals with chronic TBI. The target for tDCS application will be the left dorsolateral prefrontal cortex (DLPFC), thought to be the area associated with executive impairment in TBI patients. Study Design: Each participant will undergo an initial neuropsychological evaluation and Functional magnetic resonance imaging (fMRI). Following the preliminary evaluation, participants will undergo either tDCS or sham stimulation for 3 weeks, with follow-up assessments immediately after and 2 months later, to measure cognitive training progress. After the 2-month follow-up, participants will undergo another 3 weeks of cognitive training with either sham or tDCS, based on the participant's condition in phase 1. Post-training, there will be additional follow-ups immediately after and 2 months later.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Active tDCS on the DLPFC + Cognitive Intervention(s)	Combination Product: Active tDCS and cognitive training intervention. Participants will receive cognitive training paired with active tDCS for 3 weeks, followed by follow-up sessions immediately after and 2 months later, during which the patient's performance on the cognitive training exercises and executive functions will be assessed. Cognitive training exercises have been drawn from a computer-aided cognitive training program (BrainHQ). For the active tDCS, stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to the left DLPFC at an intensity of 2 milliamperes (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 Coulombs/cm2) in a ramp-like fashion for a maximum of 20 minutes.
COMBINATION_PRODUCT	Sham tDCS on the DLPFC + Cognitive Intervention(s)	Combination Product: Sham tDCS and cognitive training intervention Participants will receive cognitive training paired with sham tDCS for 3 weeks, followed follow-up sessions immediately after and 2 months later, during which the patient's performance on the cognitive training exercises and executive functions will be assessed. Cognitive training exercises have been drawn from a computer-aided cognitive training program (BrainHQ). For the sham tDCS, electrodes will be placed in the same area as in the active tDCS condition, but current will be administered in a ramp-like fashion but after the ramping the intensity will drop to 0 mA. Current under the Sham condition will last for a maximum of 30 seconds.

Timeline

• Start date: 2026-05-15
• Primary completion: 2029-10-15
• Completion: 2029-10-15
• First posted: 2025-05-25
• Last updated: 2026-03-25