NCT03306615进行中（未招募）2 期
Peripheral Modulation of Muscle Stiffness and Spasticity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Most affected upper limb joint passive range of motion (Cohort 1)
研究概览
简要总结
This is a single-center, double-blind, randomized, placebo-controlled, sequential Phase II trial of human recombinant hyaluronidase injections in individuals with post-stroke upper limb muscle stiffness. The investigators will recruit 56 subjects, who will be randomized to receive either the intervention or normal saline injections (first injection), and then the intervention the participants did not receive first (second injection). All individuals will receive the treatment by the end of the study.
详细描述
- To test the effect of hyaluronidase injections on upper limb outcomes. The investigators will test the hypothesis that compared to placebo, human recombinant hyaluronidase injections will increase passive range of motion (ROM) in the most affected joint of the upper limb (primary outcome), isometric muscle strength or force generation capacity using Maximum Voluntary Contraction (MVC) on electromyography (EMG), reduce upper limb motor impairment as measured by the Fugl-Meyer (FM) scale, and improve function as measured by the Wolf Motor Function Test (WMFT).
- To evaluate the effect of hyaluronidase on neural and non-neural components of muscle stiffness. The investigators will test the hypothesis that compared to placebo, intramuscular (IM) hyaluronidase will modulate the passive and potentially also the active component of the stretch reflex, reduce stiffness and improve arm motor control.
- To determine the effect of hyaluronidase on intramuscular glycosaminoglycans (GAG) content. The investigators will test the hypothesis that compared to placebo, IM hyaluronidase will reduce the T1rho relaxation times in the biceps and triceps muscles of the affected arm.
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
- Double (Participant, Care Provider)
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
- •Ischemic or hemorrhagic stroke 4-180 months prior
- •Moderately-severe muscle stiffness
- •Lack of full passive and active range of motion in at least 2/4 areas (shoulder, elbow, forearm, wrist) in the hemiparetic upper limb;
- •Willingness to have MRI, complete all clinical assessments, and comply with study protocols;
- •Ability to give informed consent and HIPPA certifications; and
排除标准
- •treatment of spasticity with Botulinum toxin or intrathecal baclofen within the past six months, phenol injections within the past 12 months, or ongoing adjustment of anti-spastic medications;
- •other neurologic condition that may affect motor response (e.g., Parkinson's disease, amyotrophic lateral sclerosis (ALS), MS);
- •clinically significant cognitive dysfunction with score <19 on Folstein's Mini Mental Status Examination or depression with score >10 on the Patient Health Questionnaire-9 (PHQ-9);
- •pregnancy;
- •known hypersensitivity to hyaluronidase;
- •claustrophobia;
- •standard contraindications for MRI
- •Any condition that will preclude the patient from completing the protocol as determined by the PI
研究组 & 干预措施
Control Arm
Placebo Comparator
Normal Saline
干预措施: Placebo (Drug)
Treatment Arm
Experimental
Hyaluronidase plus saline
干预措施: Hyaluronidase (Drug)
结局指标
主要结局
Most affected upper limb joint passive range of motion (Cohort 1)
时间窗: 9 weeks
passive range of motion in most affected joint across the upper limb
Most affected upper limb joint passive range of motion (Cohort 2)
时间窗: 15 weeks
passive range of motion in most affected joint across the upper limb
次要结局
- Total upper limb passive and active range of motion(15 weeks)
- Change in upper limb Fugl-Meyer Assessment Score(15 weeks)
- Change in Wolf-Motor Function Test (WMFT) Score(15 weeks)
研究者
研究点 (1)
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