Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation

Overview

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.

Interventions

• 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
• 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 a

Primary outcome measures

• Change in Selective attention and cognitive flexibility as assessed by the Attention Network Task (ANT) [Time frame: Before intervention, immediately after intervention]
• Change in attention and task switching as assessed by the N-Back score [Time frame: Before intervention, immediately after intervention]
• Change in Self-Ordered Pointing Task (SOPT) [Time frame: Before intervention, immediately after intervention]

Secondary outcome measures (6)

• Change in attention and task switching as assessed by the Trail Making Task [Time frame: Before intervention, immediately after intervention]
• Change in Digit Span Forward [Time frame: Before intervention, immediately after intervention]
• Change in Digit Span Backward [Time frame: Before intervention, immediately after intervention]
• Change in attention and inhibition as assessed by the Simon Task [Time frame: Before intervention, immediately after intervention]
• Change in Spatial Span Forward [Time frame: Before intervention, immediately after intervention]
• Change in Spatial Span Backward [Time frame: Before intervention, immediately after intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06989970 · IRB00353047

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗