Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation

Johns Hopkins University

Status: Not yet enrolling

Conditions: Traumatic Brain Injury

Treatments: Combination Product: Sham tDCS on the DLPFC + Cognitive Intervention(s); Combination Product: Active tDCS on the DLPFC + Cognitive Intervention(s)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06989970

IRB00353047

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of traumatic brain injury (TBI) at least 2 years prior to participation
• Right-handed
• English - speaking

Exclusion criteria

• Uncorrected visual impairment
• Uncorrected hearing impairment
• Stroke or other premorbid neurological disorders affecting the brain
• Premorbid learning disorders

MRI Exclusion Criteria:

• severe claustrophobia
• Cardiac pacemakers, ferromagnetic implants, cochlear implants
• pregnant woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Active tDCS on the DLPFC + Cognitive Intervention(s) then Sham tDCS

Active Comparator group

Description:

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.

Treatment:

Combination Product: Active tDCS on the DLPFC + Cognitive Intervention(s)

Combination Product: Sham tDCS on the DLPFC + Cognitive Intervention(s)

Sham tDCS on the DLPFC + Cognitive Intervention(s) then Active tDCS

Sham Comparator group

Description:

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

Treatment:

Combination Product: Active tDCS on the DLPFC + Cognitive Intervention(s)

Combination Product: Sham tDCS on the DLPFC + Cognitive Intervention(s)