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NCT04137146
SNS for Treatment of PD Gait Disorder
NA trial testing Sacral Nerve Stimulation in Parkinson Disease in 6 participants. Status unknown.
30 May 2021
Quick facts
| Lead sponsor | Ruijin Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 1 September 2019 |
| Primary completion | 30 May 2021 |
| Estimated completion | 31 May 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sacral Nerve Stimulation
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
- Gait Disorders, Neurologic — all drugs for Gait Disorders, Neurologic →
Sponsor
Ruijin Hospital
Who can join
Adults 45 to 70, any sex, with Parkinson Disease or Gait Disorders, Neurologic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04137146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04137146 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ruijin Hospital
- Last refreshed: 23 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04137146.
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