Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation

Sponsor
Johns Hopkins University
Study ID
NCT06989970
Status
Not Yet Recruiting

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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Active tDCS on the DLPFC + Cognitive Intervention(s) — COMBINATION_PRODUCT
    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.
  • Sham tDCS on the DLPFC + Cognitive Intervention(s) — COMBINATION_PRODUCT
    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.

Study Details

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

Key Dates

First listed
May 25, 2025
Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Oct 15, 2029
Completion
Oct 15, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active tDCS on the DLPFC + Cognitive Intervention(s) then Sham tDCS
    Participants will receive left DLPFC active tDCS for 3 weeks, followed by a follow-up immediately after and 2 months later. Active tDCS will be administered for 20 minutes. Cognitive training exercises will be administered concurrently with the tDCS and will take approximately 40 minutes to complete.
  • Sham Comparator: Sham tDCS on the DLPFC + Cognitive Intervention(s) then Active tDCS
    Participants will receive left DLPFC active tDCS for 3 weeks, followed by a follow-up immediately after and 2 months later. Cognitive training exercises will be administered concurrently with the sham tDCS and will take approximately 40 minutes to complete

Primary Outcome Measure

Change in Selective attention and cognitive flexibility as assessed by the Attention Network Task (ANT) [ Time Frame: Before intervention, immediately after intervention ]

Central Contacts

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