TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of Participants Who Complete the Study
研究概览
简要总结
The purpose of this study is to evaluate the tolerability of tDCS in childhood stroke survivors and to assess for improvement in arm function in patients receiving tDCS and occupational therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood stroke survivor - either arterial ischemic stroke or intracerebral hemorrhage.
- •Stroke must be childhood onset, defined as occurring day 29 of life to 18 years of age (per the American Heart Association's definition of childhood stroke)
- •3 months or greater from stroke onset
- •Arm impairment, defined as pediatric stroke outcome measure of 1 or greater of affected arm.
- •Affected arm Fugl-Meyer score of 60 or lower.
- •Able to participate in occupational therapy sessions.
排除标准
- •Uncontrolled epilepsy, defined as seizure within the past 6 months.
- •Craniectomy without replacement of bone flap. Patients who underwent craniectomy will need the bone flap reattached prior to participation.
- •Presence of cranial metal implants or implant device that could be affected by tDCS: cochlear implant, implanted brain stimulator, or programmable ventriculoperitoneal shunt.
结局指标
主要结局
Number of Participants Who Complete the Study
时间窗: 1-week post therapy
Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function
时间窗: 1 week post therapy
Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. Total score ranges from 0 to 66, with a higher score indicating greater arm function.
次要结局
- Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet(immediately post stimulation Day 1, immediately post stimulation Day 2, immediately post stimulation Day 3, immediately post stimulation Day 4, immediately post stimulation Day 5)
- Tolerability as Assessed by the Number of Patients With Hypotension or Hypertension on Blood Pressure Monitoring(From baseline to 1 week post-therapy session)
- Tolerability as Assessed by the Number of Patients With a Decrease in Score of 5 or Greater on the Peg-Board Test(Baseline, immediately post stimulation Day 5)
- Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function(3 month post therapy)
- Change in Quality of Unilateral Upper Limb Movement as Assessed by the Melbourne Assessment of the Upper Extremity (MUUL)(Baseline,1 week post therapy , 3 months post therapy)
研究者
Stuart Mason Fraser
Assistant Professor
The University of Texas Health Science Center, Houston