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NCT05148468
Effects of Spinal Cord Stimulation on Gait in Patients With Parkinson´s Disease
NA trial testing Active spinal cord stimulation in Parkinson Disease in 8 participants. Terminated before completion.
10 January 2024
Quick facts
| Lead sponsor | University of Sao Paulo General Hospital |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 30 November 2021 |
| Primary completion | 10 January 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Active spinal cord stimulation
- Sham spinal cord stimulation
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
- Gait Disorders, Neurologic — all drugs for Gait Disorders, Neurologic →
Sponsor
University of Sao Paulo General Hospital
Who can join
Adults 21 to 80, any sex, with Parkinson Disease or Gait Disorders, Neurologic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Spinal cord stimulation (SCS) for Parkinson´s disease (PD) has been studied for a decade but consensus on efficacy is still lacking, with the previous stimulation standard paresthesia inducing threshold hampering adequate subject blinding. Considering that tonic stimulation for pain has been shown to be efficacious for most patients on subthreshold stimulation parameters we hypothesize a similar result with it´s use on PD. The investigators aim to: 1. Produce stronger evidence on SCS efficacy for PD in regards to gait, motor scores and quality of life measures by incorporating subthreshold in a randomized cross over placebo-controlled study with a large sample. 2. Identify predictors of good response to SCS therapy by performing trans spinal magnetic stimulation (TSMS) before SCS implant and correlating the response to SCS to that of the noninvasive TSMS. 3. Better provide biomarkers of SCS therapy through functional magnetic resonance imaging and electroencephalographic mapping.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Pragmatic Review on Spinal Cord Stimulation Therapy for Parkinson's Disease Gait Related Disorders: Gaps and Controversies.
Hvingelby VS, Carra RB, Terkelsen MH, Hamani C, et al · · 2024 · cited 5× · PMID 38899557 · DOI 10.1002/mdc3.14143
Verify or expand the search:
- PubMed search for NCT05148468
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05148468 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo General Hospital
- Last refreshed: 13 May 2024
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/NCT05148468.
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