Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Adverse Events/Safety Assessment.
研究概览
简要总结
The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.
The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:
- tDCS will not produce a major adverse event, including seizure activity.
- No change in paretic or nonparetic hand function or cognitive status will occur.
详细描述
Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report.
- •Hemispheric Stroke or Periventricular Leukomalacia
- •Ages 8-17 years old
- •≥ 10 degrees of active motion at the metacarpophalangeal joint
- •Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
- •No evidence of seizure activity within the last 2 years.
- •Subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature.
排除标准
- •Metabolic Disorders
- •Disorders of Cellular Migration and Proliferation
- •Acquired Traumatic Brain Injury
- •Expressive Aphasia
- •Indwelling metal or incompatible medical devices
- •Evidence of skin disease or skin abnormalities
- •Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS
结局指标
主要结局
Adverse Events/Safety Assessment.
时间窗: Baseline, Posttest, Follow-Up Session at One-Week
Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria: 1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest. 2. Physician Evaluation- Child identified as declining in function from pretest to posttest. 3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest. Detailed adverse events are reported in the adverse events module.
次要结局
- Hand Function Decline as Measured by Number of Participants(Baseline, Posttest, Follow-Up Session at One-Week)