Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Behavioural Inattention Test (BIT)
研究概览
简要总结
Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses induce a shift to the right visual field for improving symptoms in short term.
Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency resulting from stroke with encouraging results. The hypothesis of the study is to evaluate the usefulness of brain stimulation as an adjunctive intervention to optimize and increase the rehabilitation of unilateral neglect to long-term.
Thus, the main objective is to evaluate the effectiveness of standard treatment with prismatic adaptation with anodal tDCS or sham tDCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Right-handed
- •All subjects must be between the ages of 18-80
- •Patient with unilateral negligence consecutive to a right hemispheric stroke
- •Hospitalized in the Department of Physical Medicine and Rehabilitation (day or week) or external monitoring
- •Ischemic or hemorrhagic stroke with right hemispheric topography - evidenced by a radiological report
- •Diagnosis of negligence evidenced by Behavioural Inattention Test (BIT) : score ≤ 129
- •Stroke >1 month prior to study enrollment
排除标准
- •Degenerative neurological complaint
- •Uncontrolled epilepsy
- •Temporo-spatial disorientation
- •Language disorders or psychiatric disorders preventing understanding instructions
- •History of prior stroke, multiple stroke
- •Medical condition not stabilized
- •Pregnancy
- •Implanted material (pacemaker, defibrillator, cochlear implant, surgical clips, metal object)
- •Intra-cranial material
- •Unweaned alcoholism
结局指标
主要结局
Behavioural Inattention Test (BIT)
时间窗: Change in BIT score between the baseline sessions average and score measured at week 11
assessed at two baseline sessions before intervention (inclusion and week 3), and after the therapeutic intervention week (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) following the inclusion.
次要结局
- Negligence Battery Test (BTN)(before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20))
- Jamar(baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20))
- Functional independence scale (MIF)(before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20))
- Catherine Bergego scale (ECB)(baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20))