A Novel Brain Stimulation for Bimanual Motor Function and Control in Chronic Stroke
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in Bimanual Assessment Measure (BAM)
研究概览
简要总结
The long-term goal of this project is to develop and test upper Iimb rehabilitation interventions that can improve bimanual motor function, or the ability to use both arms and hands together, for stroke survivors with moderate to severe impairment.
This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 weeks.
The study will include the following site visits:
- Eligibility Screening and Informed Consent Visit
- Baseline testing (4 visits total): 1 visit each for MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs
- Repeat baseline testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs
- 12 intervention visits during which patients will receive upper limb therapy in conjunction with non-invasive brain stimulation
- Repeat testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs
- A follow-up visit 1 month after the completion of interventions
详细描述
In a pilot randomized controlled clinical trial, 18 stroke survivors more than 6 months after stroke onset, and have upper limb impairment will be enrolled. Participants will be randomized to receive a form of non-invasive brain stimulation called repetitive transcranial magnetic stimulation or rTMS or sham rTMS. Real or sham rTMS will be delivered over an area in the brain called the higher motor cortices within the stroke-unaffected hemisphere, cHMC for short. This area (cHMC) is important for using both arms and hands together, or bimanual motor function. Real or sham cHMC rTMS will be given prior to upper limb therapy twice a week for 6 weeks in the lab. The investigators will measure bimanual motor function and control twice at the beginning, once after the 6-week treatment and once at 1-month after treatment. The investigators will also test possible mechanisms related to the treatment using brain functional MRI and TMS twice at the beginning and once after 6-week treatment.
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, Investigator, Outcomes Assessor)
盲法说明
Subjects will be told they will receive brain stimulation, but will be given no indication as to whether they will receive real or sham stimulation. Investigators analyzing functional outcome data, neurophysiology data and MRI data will receive coded data that conceals the identity of the subject. Therapists involved in training patients will not know which type of rTMS the participant receives.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90 yrs
- •≥6 months since first clinical stroke
- •Impairment of the paretic hand, indicated by a score of <= 11 out of 14 on the hand section of UEFM
- •Sufficient range of motion in the wrist and fingers for functional task practice: have at least 10 degrees active wrist extension, 10 degrees active thumb abduction/extension, and 10 degrees active extension in at least 2 additional digits
- •Sufficient active shoulder and elbow movement to volitionally position the paretic hand in the workspace for table-top task practice
排除标准
- •Brainstem or cerebellar stroke
- •Bilateral strokes or multiple strokes affecting sensorimotor structures
- •Cognitive impairment (Mini-Mental State Examination <24)
- •Severe impairment of the paretic hand that limits functional task practice (UEFM hand score < 4 out of 14)
- •Severe spasticity (Modified Ashworth Scale >3) or upper limb contracture
- •Occupational therapy or upper limb Botox completed ≤ 2 months prior
- •Contraindications to TMS or MRI (e.g. metal implant in head, seizure history, cardiac pacemaker)
结局指标
主要结局
Change in Bimanual Assessment Measure (BAM)
时间窗: Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up.
Measure of the functional ability to perform 11 bimanual tasks scoring the spontaneous role of the affected hand, timing, and quality of movement.
次要结局
- Change in Wolf Motor Function Test (WMFT)(Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up.)
- Change Resting State Functional Magnetic Resonance Imaging(rsfMRI)(Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks))
- Change in Bimanual Grip Force Modulation Task(Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up.)
- Change in ABILHAND(Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up.)
- Change in Upper Extremity Fugyl-Meyer Score (UEFM)(Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up.)
- Change in excitability of cortical and corticospinal physiology (TMS)(Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks))
研究者
Ela B. Plow
Assistant Professor
The Cleveland Clinic