tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Box and Blocks Test (BBT)
研究概览
简要总结
After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement.
The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.
详细描述
This study is a randomized clinical trail (RCT) of stroke survivors with chronic (6 to 24 months) hemiplegia randomized to: 1) conventional transcranial direct current stimulation (tDCS), 2) unconventional tDCS, or 3) sham tDCS during contralaterally controlled functional electrical stimulation mediated occupational therapy. The treatment will last 12 weeks and be followed by a 6-month follow-up period. Assessors, therapists and participants will be blinded to which tDCS treatment is received. This will be the first RCT of tDCS + CCFES.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 and ≤ 90
- •≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
- •Able to follow 3-stage command
- •Able to 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 and wrist extension
- •Skin intact on hemiparetic arm, hand and scalp
- •Muscle contraction can be elicited with Transcranial Magnetic Stimulation
- •Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale
- •Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
- •While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
排除标准
- •Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
- •Uncontrolled seizure disorder
- •Use of seizure lowering threshold medications and the discretion of the study physician
- •Cardiac pacemaker or other implanted electronic device
- •IM Botox injections in any UE muscle in the last 3 months
- •Insensate arm, forearm, or hand
- •Deficits in communication that interfere with reasonable study participation
- •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)
结局指标
主要结局
Box and Blocks Test (BBT)
时间窗: Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
次要结局
- Upper Extremity Fugl-Meyer Assessment (UEFM).(Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks)
研究者
David Cunningham
Assistant Professor
MetroHealth Medical Center