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SNS for Treatment of PD Gait Disorder

NCT04137146 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-10-23

No results posted yet for this study

Summary

Parkinson's disease (PD) is a progressive disease, characterized by dopaminergic neurons degeneration in the substantia nigra. Postural and gait disorders usually occur in advanced PD patients. However, existing drugs and deep brain stimulation (DBS) therapy are not effective enough for these axial symptoms or cannot maintain long-term efficacy, which seriously reduce patients' quality of life. Sacral nerve stimulation(SNS) is a treatment for urinary symptoms in PD. It has been reported that SNS can also improve PD gait disturbance, but the level of evidence currently is low. We assume that SNS may have a similar mechanism to spinal cord stimulation and may be an effective treatment for PD gait disorder. However, there are few studies on the mechanism of SNS treatment. Therefore, we will conduct a large sample, prospective case-control study to provide a higher level of clinical evidence for sacral nerve stimulation in the treatment of gait disturbance in PD. Our primary objective is to evaluate the efficacy of SNS for gait disorder in PD. PD patients who have received DBS surgery but still have severe gait problems will be included. This study will contribute to evaluate the efficacy of SNS for gait disorder in PD, provide level II evidence for expanding the indications of SNS, varicocelectomy., and improve patients' quality of life.

Conditions

  • Parkinson Disease
  • Gait Disorders, Neurologic

Interventions

DEVICE

Sacral Nerve Stimulation

Implantation of a sacral nerve neurostimulation system: A single electrode (Interstim® model 3889-28; Medtronic, Minneapolis, MN) was inserted bilaterally into the sacral foramen (S3), connected to an internal pulse generator (Medtronic Interstim ® II 3058)

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-05-30
Completion
2021-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137146 on ClinicalTrials.gov