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NCT Number: NCT07309133

Local Field Potentials in Dystonia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Ageing Research Unit,

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

Location status: Recruiting

Location contact

Claire Nicholson, BSc, BA, MB ChB

SUB_INVESTIGATOR

David Ledingham, MA, MBBS

CONTACT

[email protected]

+441912336161

David Ledingham, MA, MBBS

PRINCIPAL_INVESTIGATOR

Mark Baker, MA, MBBChir

SUB_INVESTIGATOR

Mohammed Hussain, BSc, MBBS

SUB_INVESTIGATOR

Nicola Pavese, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Correlation between GPi LFP peak characteristics and dystonia severity

    Time frame: Baseline (pre-activation) up to 1 year post-DBS activation

    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).

Secondary outcomes

  1. Change in LFP peak amplitude with DBS stimulation

    Time frame: Activation visit and follow-up visits up to 12 months

    Assess whether DBS stimulation parameters reduce LFP peak amplitude in the alpha-theta range during programming sessions.

  2. Relationship between LFP peak location and optimal stimulation contact

    Time frame: Baseline and follow-up to 12 months post-activation

    Evaluate whether the electrode contact with the highest LFP peak corresponds to the contact selected as optimal during traditional programming.

  3. Association between LFP changes and clinical improvement

    Time frame: Baseline and follow-up until 12 months post-activation

    Investigate whether suppression or modulation of LFP peaks correlates with improvement in dystonia severity scores.

Study contacts

Contact information is provided by the study sponsor or research team.

David Ledingham, MA, MBBS

CONTACT

[email protected]

+441912826161

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Collaborators

  • Dystonia Europe
  • Medtronic

Registry information

Official study title

Optimising Deep Brain Stimulation for Dystonia Using Local Field Potentials

Acronym: LFP-DYT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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