The Effect of Treatment With the PathMaker Myoregulator Neuromodulation System Incorporating Trans-spinal Direct Current Stimulation (tsDCS) in Patients With Severe Hand Spasticity After Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed
研究概览
简要总结
The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker anodal DoubleStim treatment, which combines non-invasive stimulation of the spinal cord (tsDCS- trans-spinal direct current stimulation) and of the median nerve at the peripheral wrist (pDCS-- peripheral direct current stimulation), can significantly reduce spasticity of the wrist and hand after stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The sham stimulation condition preceded the anodal stimulation condition for all participants, and subjects were told they would receive both conditions, but were blinded to order of assignment.
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
- •First single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- •Cognitive function sufficient to understand the experiments and follow instructions
- •A Modified Ashworth Scale score between 1-3 points for wrist flexor and extensor muscles
- •A minimum of 15 degrees wrist passive range of motion (ROM) for wrist flexion and extension from wrist neutral position
排除标准
- •Focal brainstem or thalamic infarcts
- •Prior surgical treatments for spasticity of the upper limb
- •Ongoing use of central nervous system (CNS)-active medications
- •Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
- •Botox or phenol alcohol treatment within 12 weeks of enrollment
- •Pregnancy in women, as determined by self-report
- •History of spinal cord injury or weakness
- •Chronic pain
- •Peripheral neuropathy including insulin dependent diabetes as determined by case history
- •Presence of additional potential tsDCS risk factors:
- •Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed recent scar tissue, broken skin, etc.)
- •Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
- •Highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
- •Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
结局指标
主要结局
Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed
时间窗: baseline, final session at day 5, 1 week FU
Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim)
次要结局
- Mean Modified Tardieu Scale (MTS) Score(baseline, final session at day 5, 1 week FU)
研究者
Bruce Volpe
Principal Investigator
Northwell Health