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临床试验/NCT00781833
NCT00781833终止不适用

Case Study Testing the Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury

The Alfred E. Mann Foundation for Scientific Research1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2008年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Adverse Events

研究概览

简要总结

The primary aims of this study are to determine the safety of the RFM System (Alfred Mann Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM system on lower limb strength and spasticity. The secondary aim is to analyze any improvement in the participant's mobility.

详细描述

Restoring mobility after spinal cord injury (SCI) is one of the most important goals of rehabilitation. Even for patients with partial lower limb motor function after SCI, many have limited mobility because of significant spasticity. Therapeutic electrical neuromuscular stimulation (TNS) has been used to improve muscle tone and strength and to enable walking and standing in patients with SCI. We propose to use the Radio Frequency Microstimulator (RFM) System, a new and novel implantable TNS system developed by the Alfred E. Mann Foundation, to improve muscle strength and reduce spasticity in a patient with incomplete SCI. The RFM System has several advantages over current TNS systems. The RFM implant devices are small enough (diameter 2.4 mm, length 16.7 mm) to be inserted using an incision approximately 5 mm long and have no lead wires passing through the skin since the microstimulator contains both the anode and cathode. Implanted RFM devices can be placed near multiple motor points and/or nerves and are controlled individually using radio frequency technology. Up to six (6) RFM devices will be inserted, two to three in each lower limb to provide stimulation to a patient's bilateral knee extensors (femoral nerve stimulation) and ankle dorsiflexors (peroneal nerve stimulation) to assess the effects on muscle strength, limb spasticity and patient mobility.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • an incomplete C6 ASIA C (Central Cord) spinal cord injury
  • lower motor function impaired and suffers from significant spasticity (Ashworth scale 4)
  • able to ambulate approximately 10-20 feet with a rolling walker and minimal assistance
  • has sufficient endurance to complete at least two 20-minute therapy sessions per day
  • cognitive abilities are intact

排除标准

  • psychiatric diagnosis
  • medical contraindications
  • history of bleeding disorders
  • allergy to anesthesia
  • acute or progressive disease
  • active implantable device

研究组 & 干预措施

Treatment

Experimental

Intramuscular Electrical Stimulation

干预措施: Radio Frequency Microstimulator (Device)

结局指标

主要结局

Adverse Events

时间窗: Throughout

Lower Limb Strength

时间窗: 6, 12, 24 weeks, 12, 24 months

Lower Limb Spasticity

时间窗: 6, 12, 24 weeks, 12, 24 months

次要结局

  • Mobility(6, 12, 24 weeks, 12, 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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