Browse by author
Lookup NU author(s): Dr David Ledingham, Madeleine Maynes, Anubhab Pal, Robyn IredaleORCiD, Victoria Foster, Dr Sahana Sathyanarayana, Dr Alistair Jenkins, Professor Mark BakerORCiD, Professor Nicola PaveseORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/. Introduction: Deep brain stimulation (DBS) for dystonia is effective but programming optimisation can take months. Local field potentials (LFPs) recorded by the Medtronic Percept device may provide biomarkers to guide stimulation. This study will prospectively evaluate whether chronic LFP profiles correlate with clinical outcomes and can inform DBS programming strategies. Methods and analysis: LFP-DYT is a single-centre, multi-phase observational study at Newcastle upon Tyne National Health Service (NHS) Foundation Trust. An internal pilot (Cohort 1) will refine recording workflows, followed by Cohort 2 (traditional programming with LFP recordings) and Cohort 3 (LFP-informed programming). 20–25 adults with primary dystonia undergoing globus pallidus internus DBS will be recruited. The study combines chronic LFP sensing with neurophysiology (electromyography, electroencephalography), motor inhibition testing (stop-signal reaction time), patient-reported outcomes and wearable sensor monitoring (STAT-ON) to provide a comprehensive multi-modal assessment framework. Primary outcome: reproducibility of alpha–theta frequency LFP peaks and concordance with optimal stimulation site. Secondary outcomes include stimulation and medication effects on LFP profiles, clinical improvement (Toronto Western Spasmodic Torticollis Rating Scale-2 (TWSTRS-2), Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS)) and beta-band activity as a marker of stimulation-related bradykinesia. Analyses will be descriptive and exploratory. Feasibility outcomes, including recruitment rates, retention and data completeness, will inform design and power calculations for future multi-centre trials. Ethics and dissemination: The study has NHS Research Ethics Committee approval from the East Midlands—Derby Research Ethics Committee (REC reference: 24/EM/0246; IRAS ID: 337426). All participants will provide informed consent. Data will be pseudonymised and stored on secure NHS servers. Results will be disseminated via peer-reviewed publications, conferences and participant summaries. De-identified data and analysis code will be available on reasonable request. Trial registration number: NCT07309133.
Author(s): Ledingham D, Mills R, Gibbs M, Maynes M, Pal A, Iredale R, Foster V, Ong S, Sathyanarayana S, Jenkins A, Nicholson C, Hussain M, Baker MR, Pavese N
Publication type: Article
Publication status: Published
Journal: BMJ Open
Year: 2026
Volume: 16
Issue: 5
Online publication date: 07/05/2026
Acceptance date: 23/04/2026
Date deposited: 26/05/2026
ISSN (print): 2044-6055
ISSN (electronic): 2044-6055
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/bmjopen-2026-117391
DOI: 10.1136/bmjopen-2026-117391
Data Access Statement: No datasets have been generated or analysed for this protocol. On study completion, de-identified data and analysis code will be available from the corresponding author on reasonable request, subject to institutional and regulatory requirements. No biological specimens will be stored for future unspecified use.
PubMed id: 42097654
Altmetrics provided by Altmetric
