Clinical trial NCT06989970: Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation
Official title: Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: TBI
Traumatic Brain Injury
Chronic Traumatic Brain Injury
transcranial direct current stimulation
tDCS
Computerized Cognitive Therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Ybrain Inc.
First posted: 2025-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a repeated measures crossover trial, where all participants will receive dorsolateral prefrontal cortex (DLCPFC) stimulation followed by sham stimulation or vice versa. Each condition will be separated by 2 months.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Selective attention and cognitive flexibility as assessed by the Attention Network Task (ANT)
timeFrame: Before intervention, immediately after intervention
measure: Change in attention and task switching as assessed by the N-Back score
timeFrame: Before intervention, immediately after intervention
measure: Change in Self-Ordered Pointing Task (SOPT)
timeFrame: Before intervention, immediately after intervention
Secondary outcomes:
measure: Change in attention and task switching as assessed by the Trail Making Task
timeFrame: Before intervention, immediately after intervention
measure: Change in Digit Span Forward
timeFrame: Before intervention, immediately after intervention
measure: Change in Digit Span Backward
timeFrame: Before intervention, immediately after intervention
measure: Change in attention and inhibition as assessed by the Simon Task
timeFrame: Before intervention, immediately after intervention
measure: Change in Spatial Span Forward
timeFrame: Before intervention, immediately after intervention
measure: Change in Spatial Span Backward
timeFrame: Before intervention, immediately after intervention
Other outcomes:
measure: Change in Global Cognitive Scores as assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Before intervention, immediately after intervention
measure: Change in verbal fluency task score
timeFrame: Before intervention, immediately after intervention
measure: Change in semantic content of connected speech
timeFrame: Before intervention, immediately after intervention
measure: Change in spelling as assessed by the Johns Hopkins Dysgraphia battery
timeFrame: Before intervention, immediately after intervention
measure: Change in Oral Naming as assessed by Boston Naming Test score
timeFrame: Before intervention, immediately after intervention
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Kyrana Tsapkini, PhD.
role: PRINCIPAL_INVESTIGATOR
References: