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

NCT05110053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-23

No results posted yet for this study

Summary

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

Conditions

  • Parkinson Disease
  • Gait Disorders, Neurologic
  • Fall Injury

Interventions

DEVICE

Spinal Cord Stimulation

Spinal Cord stimulation. Surgery is done in local anaesthesia. A small electrode is placed in the epidural space corresponding approximately at the Th8-Th10 level. An impulsegenerator, connected to the electrode, is placed in the subcutaneus fat in the gluteal region.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Nicola Pavese, MD, PhD, FRCP, FEAN · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-10-01
Completion
2024-06-01
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110053 on ClinicalTrials.gov