OSCR

Prospective multi-phase observational study evaluating local field potentials to guide deep brain stimulation programming in dystonia at a UK Tertiary Neurosciences Centre (LFP-DYT): a protocol.

Overview

Authors: David Ledingham1,2,3,4, Russell Mills1, Michelle Gibbs1, Madeleine Maynes2, Anubhab Pal2, Robyn Iredale2, Victoria Foster2, Stephanie Ong1, Sahana Sathyanarayana2,3,4, Alistair Jenkins1, Claire Nicholson1, Mohammed Hussain1, Mark R Baker1,3,4, Nicola Pavese1,2,3,4,5
  1. Department of Neurosciences, Newcastle Upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK
  2. Clinical Ageing Research Unit, Newcastle University, Campus for Ageing and Vitality, Newcastle upon Tyne, UK
  3. Translational and Clinical Research Institute, The Medical School, Newcastle University, Newcastle upon Tyne, UK
  4. NIHR Newcastle Biomedical Research Centre (BRC), Newcastle upon Tyne, UK
  5. Translational and Clinical Research Institute, Aarhus University Hospital Department of Nuclear Medicine & PET-Centre, Aarhus, Denmark
Institutions: NIHR Newcastle Biomedical Research Centre (United Kingdom); Newcastle University (United Kingdom); Aarhus University Hospital (Denmark)
Journal: BMJ open, volume 16, issue 5, article e117391
Dates: received 25 January 2026; accepted 23 April 2026; published online 7 May 2026
Type: Research article · Language: English
License: CC BY-NC
Identifiers: DOI 10.1136/bmjopen-2026-117391 · PMID 42097654 · PMCID PMC13157758 · OpenAlex W7160535426
Open access: gold, a free copy (OpenAlex)
Status: code on request
Categories: EEG (modality), extracellular electrophysiology (units, LFP) (modality), human (organism), other condition (population), clinical / translational (subfield)
Methods: Spectral & time-frequency, Preprocessing, Statistics, Physiology & signal measures
Keywords: Neurophysiology, Adult neurology, Neurosurgery
MeSH: Deep Brain Stimulation*, Dystonia*, Dystonic Disorders*, Adult, Electroencephalography, Female, Humans, Local Field Potential Measurement, Male, Pilot Projects, Prospective Studies, Reproducibility of Results, Research Design, United Kingdom (* major topic)
Topic: Neurological disorders and treatments (Neurology, Medicine), according to OpenAlex
Funding: Dystonia Europe; Medtronic Europe (ERP-2023-13623)
Citations: not cited yet (Europe PMC); 44 references in the paper

Abstract

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.

Reproduced under the paper's license (CC BY-NC), from the paper cited above.

Code

The paper says that its authors' code is available on request: it was not published with the paper, so there is nothing to verify.

The paper's code and data availability statement is in the Data section.

Tracing map

A tracing map links a paper to the code its authors published: this paper has none (its code is available on request), so it has no map.

Data

No dataset and no data link were found in the paper.

Data availability 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.

Reproduced under the paper's license (CC BY-NC), from the paper cited above.

Versions

The history of this record: each version stored by the harvester or made by a correction of its authors or of the maintainers of its code, and what changed in its facts. The texts of the paper (its abstract, its availability statements) are not part of it; versions that changed only those are not listed.

Version 1, 28 September 2026: the first record

Recorded: type, language, journal, volume, issue, pages, dates, 14 authors, 3 keywords, 14 MeSH terms, 2 funders, 40 references.

Cite

This paper

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, M. R., & Pavese, N. (2026). Prospective multi-phase observational study evaluating local field potentials to guide deep brain stimulation programming in dystonia at a UK Tertiary Neurosciences Centre (LFP-DYT): a protocol. BMJ open, 16(5), e117391. https://doi.org/10.1136/bmjopen-2026-117391

BibTeX

@article{ledingham2026prospective,
author = {Ledingham, David and Mills, Russell and Gibbs, Michelle and Maynes, Madeleine and Pal, Anubhab and Iredale, Robyn and Foster, Victoria and Ong, Stephanie and Sathyanarayana, Sahana and Jenkins, Alistair and Nicholson, Claire and Hussain, Mohammed and Baker, Mark R and Pavese, Nicola},
title = {{Prospective multi-phase observational study evaluating local field potentials to guide deep brain stimulation programming in dystonia at a UK Tertiary Neurosciences Centre (LFP-DYT): a protocol}},
journal = {BMJ open},
year = {2026},
month = may,
volume = {16},
number = {5},
pages = {e117391},
publisher = {BMJ Publishing Group},
issn = {2044-6055},
doi = {10.1136/bmjopen-2026-117391},
url = {https://doi.org/10.1136/bmjopen-2026-117391},
pmid = {42097654},
pmcid = {PMC13157758}
}

RIS

TY - JOUR
AU - Ledingham, David
AU - Mills, Russell
AU - Gibbs, Michelle
AU - Maynes, Madeleine
AU - Pal, Anubhab
AU - Iredale, Robyn
AU - Foster, Victoria
AU - Ong, Stephanie
AU - Sathyanarayana, Sahana
AU - Jenkins, Alistair
AU - Nicholson, Claire
AU - Hussain, Mohammed
AU - Baker, Mark R
AU - Pavese, Nicola
TI - Prospective multi-phase observational study evaluating local field potentials to guide deep brain stimulation programming in dystonia at a UK Tertiary Neurosciences Centre (LFP-DYT): a protocol
T2 - BMJ open
J2 - BMJ Open
PY - 2026
DA - 2026/05/07
VL - 16
IS - 5
SP - e117391
SN - 2044-6055
PB - BMJ Publishing Group
DO - 10.1136/bmjopen-2026-117391
UR - https://doi.org/10.1136/bmjopen-2026-117391
LA - en
ER -

CSL-JSON

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