Local Field Potentials in Dystonia

NCT07309133 | Recruiting FDA Device

• 3 other identifiers: 10878 - LFPDYT198210878
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dystonia; Dystonia, Focal; Dystonia, Primary

Keywords

Deep Brain Stimulation; DBS; Globus Pallidus Interna; Local Field Potentials; Neurostimulation; Neurophysiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in LFP peak amplitude with DBS stimulation

  Activation visit and follow-up visits up to 12 months

• Relationship between LFP peak location and optimal stimulation contact

  Baseline and follow-up to 12 months post-activation

• Association between LFP changes and clinical improvement

  Baseline and follow-up until 12 months post-activation

Study Arms (3)

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

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

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

Interventions

Deep Brain Stimulation System DEVICE

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 1 (Pilot group); Cohort 2 (Main observational group); Cohort 3 (Exploratory programming group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• Medtronic: collaborator
• Dystonia Europe: collaborator

Study Sites (1)

Clinical Ageing Research Unit,

Newcastle upon Tyne, Tyne & Wear, NE4 6BE, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 40470846 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Dystonia; Dystonic Disorders

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases

Central Study Contacts

David Ledingham, MA, MBBS

CONTACT

+441912826161; david.ledingham1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)