Combined Brain and Peripheral Nerve Stimulation to Enhance Beneficial Effects of Functional Electrical Stimulation on Hand Motor Function After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Active Range of Motion of Wrist Extension in the Paretic Side
研究概览
简要总结
Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. We will non-invasively stimulate the brain and peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that brain stimulation, when added to peripheral nerve stimulation, will enhance effects of motor training to a greater extent than brain stimulation alone, peripheral stimulation alone, or no stimulation.
详细描述
The goal of this study is to compare the effects of FES in close association with either transcranial direct current stimulation (tDCS) alone, peripheral nerve stimulation (PNS)alone, tDCS + PNS or sham tDCS + sham PNS, in patients with moderate to severe upper limb weakness, in a cross-over design. The working hypothesis of this proof-of-principle study is that either tDCS or PNS will enhance effects of functional electrical stimulation (FES) to a greater extent than placebo tDCS and PNS, and that the combination of tDCS and PNS will further improve motor outcomes than either tDCS or PNS alone.
The interventions will consist of outpatient motor training of the paretic wrist with FES in four experimental sessions separated by two weeks. In each session, either active tDCS + sham PNS, active PNS + sham tDCS,active tDCS + active PNS or sham tDCS + sham PNS will be applied. PNS will be applied for 2 hours and tDCS will be applied in the last 20 minutes before completion of PNS. The order of the sessions will be randomized across patients. Before the first session, patients will be familiarized with the FES device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, 18 years or older;
- •First-ever, ischemic or hemorrhagic stroke at least six months before, confirmed by computed tomography or magnetic resonance imaging;
- •Moderate to severe motor impairment of an upper limb, defined as a score between 7 and 50 on the Fugl-Meyer Assessment of Sensorimotor Recovery after stroke, a scale with scores for upper limb ranging from 0 (no function) to 66 (normal function;
- •Ability to provide written Informed Consent (patient or legal representative);
- •Ability to comply with the schedule of interventions and evaluations in the protocol.
排除标准
- •Lack of ability to voluntarily activate any active range of wrist extension;
- •Anesthesia of the paretic hand;
- •Stroke lesions affecting entirely the hand knob area of the motor cortex120;
- •Stroke lesions affecting the cerebellum or the brain stem;
- •Severe spasticity at the paretic elbow, wrist, or fingers, defined as a score of >3 on the Modified Ashworth Spasticity Scale;
- •Active joint deformity;
- •Uncontrolled medical problems such as end-stage cancer or renal disease;
- •Pregnancy;
- •Seizures;
- •Pacemakers;
- •Other neurological disorders such as Parkinson's disease;
- •Psychiatric illness including severe depression;
- •Aphasia or serious cognitive deficits that preclude comprehension of the experimental protocol or ability to provide consent. A score in the Minimental State Examination lower than 23/30 points will be used for patients with higher than 1 year of education, and a score lower than 19/30 will be used for patients with 1 year of education or less.
研究组 & 干预措施
Active tDCS and active PNS
1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)
干预措施: Active tDCS (Other)
Active tDCS and active PNS
1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)
干预措施: Active PNS (Other)
Active tDCS and sham PNS
1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)
干预措施: Active tDCS (Other)
Active tDCS and sham PNS
1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)
干预措施: Sham PNS (Other)
Sham tDCS and active PNS
1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)
干预措施: Active PNS (Other)
Sham tDCS and active PNS
1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS)
干预措施: Sham tDCS (Other)
Sham tDCS and sham PNS
1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)
干预措施: Sham tDCS (Other)
Sham tDCS and sham PNS
1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)
干预措施: Sham PNS (Other)
结局指标
主要结局
Active Range of Motion of Wrist Extension in the Paretic Side
时间窗: Pre- and post-intervention on each intervention day
In this cross-over study, the primary outcome was measured immediately before and after each session of treatment. In each session, one of the four possible interventions was administered.
次要结局
未报告次要终点
研究者
Adriana Bastos Conforto
Professor
University of Sao Paulo General Hospital