Taking people in United KingdomNo phase

Using brain signals to help adjust deep brain stimulation for dystonia

Studies whether brain signals can guide stimulation settings in adults with dystonia.

Key facts

Who runs it: Newcastle-upon-Tyne Hospitals NHS Trust
Where: Newcastle upon Tyne, United KingdomSee the site
Trial code: NCT07309133
Registry title: Local Field Potentials in Dystonia
Status: Recruiting
People taking part: 25 people, planned
Started: 4 Sept 2025
Expected to end: Dec 2028
Type of study: Observational, 3 groups
Treatments tested: Deep Brain Stimulation System
Record updated: 30 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with primary dystonia who are planned to have deep brain stimulation (DBS) surgery in the GPi, a deep brain area. It studies whether brain signals recorded by the device can help set up DBS.

Age: 18 years or older
Sex: All sexes
Disease stage: Clear diagnosis of primary dystonia, idiopathic (no known cause) or genetic forms. People must be candidates for GPi DBS surgery.
Earlier treatment: People who took part in a research trial testing a treatment within the last year cannot join.

Main reasons for not taking part

Serious neurological or psychiatric disorder, including dementia, that would interfere with judging results
Taking part in a research trial testing a treatment within the last year
Functional (psychogenic) dystonia
Not able to give informed consent

The registry criteria, word for word

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Who can take part

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

Who cannot take part

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

Where in United Kingdom

Clinical Ageing Research Unit,Newcastle upon Tyne, United KingdomContact: David Ledingham, MA, MBBSTaking people

About the trial

What the trial wants to find out

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.

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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.

The 3 groups in the trial

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.
Treatment: 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.
Treatment: 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.
Treatment: Deep Brain Stimulation System