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NCT05110053: STEP-PD

Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems

Completed NA Last updated 23 May 2025
What this trial tests

NA trial testing Spinal Cord Stimulation in Parkinson Disease in 12 participants. Completed in 1 June 2024.

Timeline
1 September 2021
Primary endpoint
1 October 2023
1 June 2024

Quick facts

Lead sponsorUniversity of Aarhus
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment12
Start date1 September 2021
Primary completion1 October 2023
Estimated completion1 June 2024
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

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.

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Other trials of Spinal Cord Stimulation

Trials testing the same drug.

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Other University of Aarhus trials

Trials by the same sponsor.

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Data sources for this page

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