Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation

Обзор

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

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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
• Комбинированный продукт 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

Первичные конечные точки

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

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06989970 · IRB00353047

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗