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Local Field Potentials in Dystonia

NCT07309133 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2025-12-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Dystonia Europe

    collaborator UNKNOWN

  • Newcastle-upon-Tyne Hospitals NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309133 on ClinicalTrials.gov