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Lookup NU author(s): Professor Nicola PaveseORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
© The Author(s) 2026.A trial of spinal cord stimulation (SCS) was performed in people with gait-impaired Parkinson’s (ClinicalTrials.gov: NCT05110053). Fourteen patients underwent gait assessments and [18F]-FDG and [18F]-FEOBV PET at baseline, six, and twelve months after SCS. Twelve participants were randomised to six-month MicroBurst or sham, followed by six-month extension with stimulation. The primary outcomes were feasibility and safety, as captured by the trial process measures and nature and frequency of adverse events, respectively, and the Postural Instability and Gait Disorder (PIGD) score as a clinical outcome. Secondary outcomes included assessments of balance and gait at home and at visits, including the Lower Body and Gait (LBG) score, imaging, and patient-reported outcomes of changes in gait, balance and quality of life. Seventeen patients (12%) were eligible for enrolment. Recruitment was feasible (1.2 participants/month) and SCS was well-tolerated. At six months, MicroBurst did not significantly improve gait compared with sham, although bradykinesia/rigidity improved. At 12 months, LBG scores improved (−4.31 points, p = 0.0012) with bilateral decreased thalamic metabolism and decreased right anterior insula [18F]-FEOBV uptake. The trial met its primary feasibility and safety endpoints by achieving recruitment targets and demonstrating that SCS was well-tolerated. However, it did not meet the primary clinical endpoint of a significant PIGD improvement at six months. Larger trials are warranted, as SCS may improve LBG and leg rigidity/bradykinesia, especially as time progresses. We reported data for power calculations and identified important risks for designing future trials.
Author(s): Terkelsen MH, Hvingelby VS, Johnsen EL, Moller M, Danielsen EH, Henriksen T, Glud AN, Tai Y, Baun AM, Knudsen AL, Valdemarsen RN, Horsager J, Okkels N, Andersen ASM, Meier K, Borghammer P, Molloy S, Nandi D, Moro E, Sorensen JCH, Pavese N
Publication type: Article
Publication status: Published
Journal: Nature Communications
Year: 2026
Volume: 17
Issue: 1
Print publication date: 04/03/2026
Online publication date: 29/01/2026
Acceptance date: 16/01/2026
Date deposited: 17/03/2026
ISSN (electronic): 2041-1723
Publisher: Nature Research
URL: https://doi.org/10.1038/s41467-026-68782-w
DOI: 10.1038/s41467-026-68782-w
Data Access Statement: The imaging data are available under restricted access for anonymity; access can be obtained by requests directed to the corresponding author, whowill review requests on acase-by-casebasis inaccordance with Danish legal and ethical regulations. Response can be expected within two weeks. All source data and clinical, individual-level data generated in this study are provided in the Supplementary Materials/ Source Data files. Source data are provided with this paper.
PubMed id: 41611672
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