Local Field Potentials in Dystonia (LFP-DYT)

Optimising Deep Brain Stimulation for Dystonia Using Local Field Potentials

The goal of this clinical trial is to learn whether local field potential (LFP) signals recorded from the globus pallidus interna (GPi) using the Medtronic Percept™ deep brain stimulation (DBS) device can help optimize DBS programming for people with dystonia. The study will also explore whether LFP patterns can serve as a biomarker of disease activity and predict treatment response.

The main questions it aims to answer are:

Do LFP peaks in the alpha-theta range reliably correlate with dystonia severity and clinical characteristics? Can LFP-based programming achieve similar or better clinical outcomes compared to traditional programming methods? How do LFP profiles change with stimulation and other treatments such as botulinum toxin or oral medications?

Researchers will compare two programming approaches:

Traditional programming based on clinical assessment and imaging. LFP-guided programming based on the site and characteristics of LFP peaks

Participants will:

Undergo DBS surgery for dystonia as part of standard clinical care. Attend regular follow-up visits for DBS programming and outcome assessments. Complete clinical rating scales for dystonia severity, quality of life, cognition, and mood.

Take part in neurophysiological assessments, including surface EMG, EEG, and reaction time tasks.

Have LFP recordings collected using the Medtronic Percept™ device during clinic visits and, where possible, at home using device sensing features.

This study will help determine whether LFP analysis can shorten the time to optimal DBS settings and improve outcomes for people with dystonia.

Study Overview

• Status: Recruiting
• Conditions: Dystonia; Dystonia, Primary; Dystonia, Focal
• Intervention / Treatment: Device: Deep Brain Stimulation System

Detailed Description

Dystonia is a disabling movement disorder characterized by sustained or intermittent muscle contractions that cause abnormal postures and movements. Deep brain stimulation (DBS) of the globus pallidus interna (GPi) is an established treatment for patients who do not respond adequately to first-line therapies such as botulinum toxin. However, clinical response to DBS in dystonia is highly variable, and optimization of stimulation settings often requires months of trial and error. This delay can prolong disability and increase healthcare burden.

Local field potentials (LFPs) are neural signals recorded from implanted DBS electrodes. In Parkinson's disease, LFP analysis has been used to guide programming and develop adaptive stimulation strategies. In dystonia, early studies suggest that low-frequency LFP peaks (typically in the alpha-theta range) may correlate with disease severity and optimal stimulation sites, but these findings have been limited to short-term recordings using externalized leads. The Medtronic Percept™ DBS system now allows chronic sensing of LFPs during routine clinical care, creating an opportunity to validate these observations and assess their clinical utility.

This single-site, prospective study will evaluate whether LFP profiles recorded from the GPi can guide DBS programming in patients with primary dystonia. The study includes an internal pilot phase followed by two main cohorts. Cohort 2 will undergo traditional programming based on clinical assessment and imaging, with LFP recordings collected at each visit. Cohort 3 will use an LFP-guided approach, selecting contacts and stimulation parameters based on the site and characteristics of LFP peaks. Participants will be followed for up to 12 months, with blinded video assessments and standardized rating scales to compare outcomes between programming strategies. Neurophysiological measures such as surface electromyography (EMG), electroencephalography (EEG), and reaction time tasks will also be collected to explore mechanistic links between stimulation and motor control.

The study aims to determine whether LFP analysis can shorten the time to optimal DBS settings and improve clinical outcomes compared to traditional methods. If successful, this approach could inform future development of adaptive DBS systems for dystonia, reducing variability in care and improving patient quality of life.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: David Ledingham, MA, MBBS; Phone Number: +441912826161; Email: david.ledingham1@nhs.net

Study Locations

• United Kingdom
  • Tyne & Wear
    • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE4 6BE
      • Recruiting
      • Clinical Ageing Research Unit,
      • Contact: David Ledingham, MA, MBBS; Phone Number: +441912336161; Email: david.ledingham1@nhs.net
      • Principal Investigator: David Ledingham, MA, MBBS
      • Sub-Investigator: Nicola Pavese, MD, PhD
      • Sub-Investigator: Mark Baker, MA, MBBChir
      • Sub-Investigator: Mohammed Hussain, BSc, MBBS
      • Sub-Investigator: Claire Nicholson, BSc, BA, MB ChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) with a clinical diagnosis of primary dystonia (including idiopathic adult-onset focal cervical dystonia and young-onset generalized dystonia such as DYT1).

All participants are scheduled to undergo deep brain stimulation (DBS) of the globus pallidus interna (GPi) as part of standard clinical care.

Description

Inclusion Criteria:

• Age 18 years or older at screening.
• Clear clinical diagnosis of primary dystonia (idiopathic or genetic forms).
• Candidate for GPi DBS surgery for dystonia treatment.
• Able to provide informed consent.

Exclusion Criteria:

• Significant neurological or psychiatric disorder (including dementia) that would interfere with outcome evaluation.
• Participation in a therapeutic research trial within the last year.
• Diagnosis of functional (psychogenic) dystonia.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 (Pilot group); Description: First 3 participants with primary dystonia undergoing DBS. Used to optimize LFP sensing workflow and confirm the feasibility of data collection. Population: Adults (≥18 years) with primary dystonia scheduled for GPi DBS. Purpose: Workflow development and initial LFP data collection.	Device: Deep Brain Stimulation System; The Medtronic Percept™ DBS system will be used as part of standard clinical care for dystonia. The study will utilize the device's sensing capabilities (BrainSense™) to record local field potentials for research purposes.
Cohort 2 (Main observational group); Description: 8-10 participants with primary dystonia undergoing DBS and programmed using traditional clinical methods. LFP recordings are collected at each visit for correlation analysis. Population: Adults with primary dystonia (including idiopathic cervical dystonia and generalized dystonia). Purpose: Assess the relationship between LFP profiles and optimal stimulation sites determined by standard programming.	Device: Deep Brain Stimulation System; The Medtronic Percept™ DBS system will be used as part of standard clinical care for dystonia. The study will utilize the device's sensing capabilities (BrainSense™) to record local field potentials for research purposes.
Cohort 3 (Exploratory programming group); Description: 10-15 participants with primary dystonia who may receive programming guided by LFP analysis if interim results support feasibility. Population: Adults with primary dystonia undergoing DBS. Purpose: Explore whether LFP-guided programming improves clinical outcomes compared to traditional methods.	Device: Deep Brain Stimulation System; The Medtronic Percept™ DBS system will be used as part of standard clinical care for dystonia. The study will utilize the device's sensing capabilities (BrainSense™) to record local field potentials for research purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between GPi LFP peak characteristics and dystonia severity	Assess whether local field potential (LFP) peaks recorded from the globus pallidus interna using the Medtronic Percept™ DBS system correlate with clinical severity of dystonia as measured by standardized rating scales (e.g., TWSTRS for cervical dystonia, BFMDRS for generalized dystonia).	Baseline (pre-activation) up to 1 year post-DBS activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LFP peak amplitude with DBS stimulation	Assess whether DBS stimulation parameters reduce LFP peak amplitude in the alpha-theta range during programming sessions.	Activation visit and follow-up visits up to 12 months
Relationship between LFP peak location and optimal stimulation contact	Evaluate whether the electrode contact with the highest LFP peak corresponds to the contact selected as optimal during traditional programming.	Baseline and follow-up to 12 months post-activation
Association between LFP changes and clinical improvement	Investigate whether suppression or modulation of LFP peaks correlates with improvement in dystonia severity scores.	Baseline and follow-up until 12 months post-activation

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Collaborators: Medtronic; Dystonia Europe

Publications and helpful links

General Publications

• Ledingham D, Gibbs M, Mills R, Jenkins A, Nicholson C, Hussain MA, Baker M, Pavese N. Decoding Cervical Dystonia: Insights from Local Field Potentials in a Case Study Utilizing Open-Source Toolboxes. Mov Disord Clin Pract. 2025 Oct;12(10):1675-1678. doi: 10.1002/mdc3.70164. Epub 2025 Jun 5. No abstract available.
• Ledingham D, Baker M, Pavese N. Local field potentials: Therapeutic implications for DBS in dystonia including adaptive DBS for dystonia. Deep Brain Stimulation. 2024;5:4-19. doi:10.1016/j.jdbs.2024.03.003

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; DBS; Neurophysiology; Neurostimulation; Globus Pallidus Interna; Local Field Potentials
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Dyskinesias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dystonia; Dystonic Disorders
• Other Study ID Numbers: 10878 - LFPDYT; 1982 (Other Identifier: Clinical Ageing Research Unit); 10878 (Other Identifier: Newcastle Hospitals R&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be stored securely and used only for approved analyses; summary results will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No