Contralaterally Controlled FES Plus Transcranial Direct Current Stimulation for Hand Motor Control After Stroke: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Corticospinal Excitability
研究概览
简要总结
This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
- •Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes
- •Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
- •Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
- •Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
- •Medically stable
- •≥ 10° finger extension
- •Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test AND a score of
- •≥1 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
- •Skin intact on hemiparetic arm, hand and scalp
- •While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
- •No significant visual or hearing impairment
排除标准
- •Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis).
- •Uncontrolled seizure disorder
- •Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
- •Cardiac pacemaker or other implanted electronic device and/or stent
- •Intramuscular botox injections in any upper extremity muscle in the last 3 months
- •Insensate arm, forearm, or hand
- •Severely impaired cognition and communication
- •Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
- •Severe shoulder or hand pain (unable to position hand in the workspace without pain)
- •Metal implant in the head
结局指标
主要结局
Corticospinal Excitability
时间窗: up to one hour post intervention
Change in corticospinal excitability will be measured with transcranial magnetic stimulation
Reaction Time
时间窗: up to one hour post intervention
Change in reaction time will be assessed with visual and auditory cues.
次要结局
未报告次要终点
研究者
David Cunningham
Assistant Professor, Physical Medicine and Rehabilitation, School of Medicine
MetroHealth Medical Center