Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 60
- 主要终点
- Changes in the Box and Blocks test
研究概览
简要总结
The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. Ability to cooperate and follow simple directions.
排除标准
- •Seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tDCS or TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- •True positive response on the Transcranial Magnetic Stimulation and MRI Safety Screen
- •Current use of medications known to lower the seizure threshold
- •Previous episode of unprovoked neurocardiogenic syncope
- •Indwelling metal or incompatible medical devices
- •Centrally-acting medications including anti-seizure medications
- •Evidence of scalp disease or skin abnormalities
- •Current medical illness unrelated to CP
- •High motor ability in affected arm (i.e. no asymmetry in scores of hand function)
- •Severe spasticity
- •Lack of asymmetry in hand function
- •Orthopedic surgery in affected arm
- •Botulinum toxin therapy in either upper extremity during last 6 months, or planned during study period
- •Currently receiving intrathecal baclofen
- •History of broken arm (either arm) 1 year prior to study enrollment
研究组 & 干预措施
Active tDCS + motor training
In this arm, participants will receive 20 minutes of active tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games.
干预措施: active transcranial direct current stimulation (Device)
Active tDCS + motor training
In this arm, participants will receive 20 minutes of active tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games.
干预措施: Motor training (Behavioral)
Sham tDCS + motor training
In this arm, participants will receive 20 minutes of sham tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. Children receiving sham tDCS will wear the tDCS device but not receive active stimulation.
干预措施: Motor training (Behavioral)
结局指标
主要结局
Changes in the Box and Blocks test
时间窗: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Investigators will measure changes in the movement speed of the hands.
Changes in the Assisting Hand Assessment
时间窗: Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities.
次要结局
- Changes in Motor-evoked Potential assessment(Day before intervention begins, compared to day after intervention ends (approximately 1 week))
研究者
Claudio
Assistant Professor
Boston University Charles River Campus