RecruitingNCT07309133

Local Field Potentials in Dystonia

Optimising Deep Brain Stimulation for Dystonia Using Local Field Potentials


Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Enrollment

25 participants

Start Date

Sep 4, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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.

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Interventions

DEVICEDeep 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.


Locations(1)

Clinical Ageing Research Unit,

Newcastle upon Tyne, Tyne & Wear, United Kingdom

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NCT07309133


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