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NCT05110053: STEP-PD
Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems
NA trial testing Spinal Cord Stimulation in Parkinson Disease in 12 participants. Completed in 1 June 2024.
1 October 2023
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 September 2021 |
| Primary completion | 1 October 2023 |
| Estimated completion | 1 June 2024 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Spinal Cord Stimulation
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
- Gait Disorders, Neurologic — all drugs for Gait Disorders, Neurologic →
- Fall Injury — all drugs for Fall Injury →
Sponsor
University of Aarhus
Who can join
50 and older, any sex, with Parkinson Disease or Gait Disorders, Neurologic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Gait difficulties are common in Parkinson's disease (PD) and cause significant disability. No treatment is available for these symptoms. Spinal Cord Stimulation (SCS) has been found to improve gait, including freezing of gait, in a small number of PD patients. The mechanism of action is unclear and some patients are nonresponders. With this double-blind placebo-controlled proof of concept and feasibility imaging study, we aim to shed light on the mechanism of action of SCS and collect data to inform development of a scientifically sound clinical trial protocol. We also hope to identify imaging biomarkers at baseline that could be predictive of a favourable or a negative outcome of SCS and improve patient selection. Patients will be assessed with clinical rating scales and gait evaluations at baseline and 6 and 12 months after SCS. They will also receive serial 18F-FDG and (\[18F\]FEOBV) PET scans to assess the effects of SCS on cortical/subcortical activity and brain cholinergic function
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05110053
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06176391 — SCS for Vasospastic Angina Vasospastic Angina Pectoris - a Prospective Study · NA · unknown
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Other recruiting trials for Parkinson Disease
Currently open trials in the same condition.
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- NCT06848205 — Percept Transitions in FOG and PD · NA · recruiting
- NCT07432958 — A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (P · Phase 2 · recruiting
Other University of Aarhus trials
Trials by the same sponsor.
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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 NCT05110053 (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 University of Aarhus
- Last refreshed: 23 May 2025
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/NCT05110053.
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