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临床试验/NCT02388204
NCT02388204Unknown不适用

Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Changes in locomotion capacity

研究概览

简要总结

Although DBS improves patient's quality of life advanced Parkinson's patients (PD) by addressing the cardinal symptoms and reducing levodopa motor complications, symptoms still worsen over time. Postural problems, frequent falls, freezing of gait impairment and other locomotion difficulties still remain as important causes of disability and incapacity. Novel therapeutics approaches are needed to restore quality of life (QoL).

This study aims to explore the effects of spinal cord stimulation in locomotion, falls and freezing of gait in advanced PD patients.

Twenty PD patients will undergo thoracic spinal cord stimulation at high frequencies in a prospective study for six months.

Changes in locomotion capacity and freezing of gait rating will be the primary out come. Secondary outcomes will be: QoL and common motor outcome measures in PD patients. Always comparing the status before, one, three and six months after stimulation was initiated. A double blind trial will be performed within three months of follow up (high X low frequency stimulation).

详细描述

Background: Currently there are no available Parkinson's disease (PD) therapy can really stop disease progression. Although Deep Brain Stimulation (DBS) improves patient's quality of life by addressing the cardinal symptoms and reducing Levodopa motor complications, non motor symptoms still increasing over time. Gait problems as falls and freezing are important cause of disability and incapacity. Novel therapeutics approaches are needed to restore quality of life. Data from animal PD model suggest that spinal cord stimulation (SCS) can enhance locomotion in mice. Although clinical results, mostly from case reports, in PD patients are still conflicting, a few patients benefited from SCS in thoracic levels.

Aim: Evaluated Spinal cord stimulation effects in locomotion, gait, freezing and falls in PD patient's.

Method: 20 PD patients will undergo thoracic spinal cord stimulation with high frequency in a prospective study for six months. Gait and freezing evaluation will consists in: timed up and go test, timed up and go test with dual task, 20 m walk test, 20 m walk test with obstacle, freezing of gait scale and falls scale. PDQ 39 and Schwab and England scales will be used to measure quality of life. Unified Parkinson's Disease Rating Scale for motor symptoms and general evaluation. All tests will be done before surgery, after one week, one, three, six months. All patients will be stimulated with the same parameters: High frequencies and 90 mcs pulse width and the sensory threshold will be measured. At the third month the parameters of SCS will be changed and comparative tested for low frequency in a double blind trail.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic PD
  • Gait and locomotion problems as the main complain/symptom
  • PD patients with or without DBS
  • Hoehn and Yahr scale equal or more than 2.0

排除标准

  • Hoehn and Yahr scale more than 4
  • Less than 5 years of Parkinson's disease symptoms
  • General contraindications of surgery

结局指标

主要结局

Changes in locomotion capacity

时间窗: 6 months

"Timed-up-go" test : time to complete the test : difference between scores pre-implantation and 6 months after stimulation initiation "20 meters walking test": time and steps numbers to complete the test "20 meters walking test- with obstacles": time and steps numbers to complete the test : difference between scores pre-implantation and 6 months after stimulation initiation "Dual task Timed-up-go" test : time to complete the test : difference between scores pre-implantation and 6 months after stimulation initiation "Dual task Timed-up-go" test : time to complete the test : difference between scores pre-implantation and 6 months after stimulation initiation

次要结局

  • Changes in quality of life(6 months)
  • Motor changes(6 months)
  • Changes in freezing of Gait(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erich Talamoni Fonoff

Professor of Neurosurgery

University of Sao Paulo

研究点 (2)

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