Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Assessment from baseline
研究概览
简要总结
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.
详细描述
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of four groups by chance. Three groups will receive tDCS at a level expected to increase the brain's ability to change, and will vary by the areas of the brain that are stimulated. The fourth group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their impaired arm and hand, focusing on exercises that will improve their ability to function in daily life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 or more months post-stroke
- •Inability to extend the affected metacarpophalangeal joints at least 10 degrees and the wrist 20 degrees
排除标准
- •Addition or change in dosage of drugs known to exert detrimental effects on motor recovery within 3 month of enrollment
- •Untreated depression
- •History of multiple strokes
- •Exclusion criteria for TMS evaluations:
- •History of head injury with loss of consciousness
- •History of severe alcohol or drug abuse, or psychiatric illness
- •Positive pregnancy test or being of childbearing age and not using appropriate contraception
- •Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain
- •Cardiac or neural pacemakers
研究组 & 干预措施
Anodal tDCS
Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
干预措施: transcranial direct current stimulation (Device)
Anodal tDCS
Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
干预措施: intensive upper extremity motor training (Behavioral)
Cathodal tDCS
Subjects will receive 20 minutes of active, excitatoryinhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
干预措施: transcranial direct current stimulation (Device)
Cathodal tDCS
Subjects will receive 20 minutes of active, excitatoryinhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
干预措施: intensive upper extremity motor training (Behavioral)
Dual tDCS
Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere and inhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
干预措施: transcranial direct current stimulation (Device)
Dual tDCS
Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere and inhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
干预措施: intensive upper extremity motor training (Behavioral)
Sham tDCS
Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity.
干预措施: transcranial direct current stimulation (Device)
Sham tDCS
Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity.
干预措施: intensive upper extremity motor training (Behavioral)
结局指标
主要结局
Change in Fugl-Meyer Assessment from baseline
时间窗: Baseline, Immediately post-intervention, one-month follow-up
This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.
次要结局
- Change in cortical motor map from baseline(Baseline, Immediately post-intervention, one-month follow-up)
- Change in Action Research Arm Test from baseline(Baseline, Immediately post-intervention, one-month follow-up)
- Change in Stroke Impact Scale from baseline(Baseline, Immediately post-intervention, one-month follow-up)
研究者
Lumy Sawaki
Associate Professor
University of Kentucky