NCT05110053Completed
Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems
Source: ClinicalTrials.gov · Last updated 23 May 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 23 Sept 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 1 Oct 2023
- Lead sponsor
- University of Aarhus
- Diseases
- Parkinson disease
- NCT number
- NCT05110053
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 1 Sept 2021 to the primary completion date, 1 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Spinal anatomical abnormalities precluding SCS surgery
- Previous DBS surgery for PD
Other illness
- The presence of another significant neurological/psychiatric disorder or significant disease
- History of stroke or structural lesions on CT that could interfere with image analysis.
- History of chronic pain and severe degenerative spine disease with or without chronic pain
- History of drug addiction or dependency
Other
- Pregnancy or breast-feeding.
Who the study is looking for
- Idiopathic PD diagnosed by a movement disorders neurologist
- Presence of gait functional impairment despite optimal medical management
- Able to walk independently without an aid for a minimum of two minutes without rest
- Absence of secondary causes of gait problems
- Able to understand study requirements - able to provide consent
- Above 50 years of age
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.