Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Change in Selective attention and cognitive flexibility as assessed by the Attention Network Task (ANT)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Both interventions, whether involving tDCS or sham stimulation, will entail a gradual increase in electrical current at the commencement of the stimulation, inducing a transient tingling sensation on the scalp that typically dissipates within seconds. While the ramping process necessitates input from the researcher, it is now feasible to implement blinding procedures for study staff administering tDCS and participants. This is facilitated by a device that enables another team member to designate the setting as "tDCS" or "sham" without the therapist's knowledge. Following the ramping phase, in the sham condition, the intensity of stimulation decreases to 0 mA.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of traumatic brain injury (TBI) at least 2 years prior to participation
- •Right-handed
- •English - speaking
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sham tDCS on the DLPFC + Cognitive Intervention(s) (Combination Product)
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
干预措施: Active tDCS on the DLPFC + Cognitive Intervention(s) (Combination Product)
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
干预措施: Sham tDCS on the DLPFC + Cognitive Intervention(s) (Combination Product)
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.
干预措施: Active tDCS on the DLPFC + Cognitive Intervention(s) (Combination Product)
结局指标
主要结局
Change in Selective attention and cognitive flexibility as assessed by the Attention Network Task (ANT)
时间窗: Before intervention, immediately after intervention
This will be measured using the Attention Network Task (ANT). An efficiency score for executive attention is derived by comparing scores on trials with congruent flankers to trials with incongruent flankers. Subjects will tend to be slower and less accurate for incongruent trials, the size of the difference indicates the extent to which an individual can supress conflicting response tendencies. A larger difference between congruent and incongruent trials score indicates a lower executive efficiency (score range: 0-96)..
Change in attention and task switching as assessed by the N-Back score
时间窗: Before intervention, immediately after intervention
The N-back task is a well-established task that assesses working memory and working memory capacity. Participants are presented with words in sequence and instructed to reply whether the current word matches the one presented 2 words ago (2-back). Scoring will be based on the total number of correct responses (hit rate) minus the number of incorrect responses (false alarm rate), where a greater score is better (score range: 0-80).
Change in Self-Ordered Pointing Task (SOPT)
时间窗: Before intervention, immediately after intervention
The SOPT is a test used to assess executive functioning. In this task, participants are shown a series of pages, each displaying the same set of abstract images arranged in a random order. On each page, the participant must point to one image, ensuring not to select the same image more than once across the entire series. A correct response involves selecting a previously un-chosen image, while an error is recorded when a participant selects an image already chosen on a previous page. Performance will be measured by total number of errors measured out of the total number of possible responses, with a higher error count indicating greater impairment.
次要结局
- Change in attention and task switching as assessed by the Trail Making Task(Before intervention, immediately after intervention)
- Change in Digit Span Forward(Before intervention, immediately after intervention)
- Change in Digit Span Backward(Before intervention, immediately after intervention)
- Change in attention and inhibition as assessed by the Simon Task(Before intervention, immediately after intervention)
- Change in Spatial Span Forward(Before intervention, immediately after intervention)
- Change in Spatial Span Backward(Before intervention, immediately after intervention)