An observational study in Dystonia, Dystonia, Focal and Dystonia, Primary, sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Newcastle-upon-Tyne Hospitals NHS Trust · Observational
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.
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.
213 studies on the registry are indexed under Dystonia; 54 are open to participants now.
This study's planned enrollment of 25 is below the median of 78 across 90 observational studies indexed under Dystonia.
Browse Dystonia studies →Newcastle-upon-Tyne Hospitals NHS Trust is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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).
Time frame: Baseline (pre-activation) up to 1 year post-DBS activation
Change in LFP peak amplitude with DBS stimulation
Assess whether DBS stimulation parameters reduce LFP peak amplitude in the alpha-theta range during programming sessions.
Time frame: Activation visit and follow-up visits up to 12 months
Relationship between LFP peak location and optimal stimulation contact
Evaluate whether the electrode contact with the highest LFP peak corresponds to the contact selected as optimal during traditional programming.
Time frame: Baseline and follow-up to 12 months post-activation
Association between LFP changes and clinical improvement
Investigate whether suppression or modulation of LFP peaks correlates with improvement in dystonia severity scores.
Time frame: Baseline and follow-up until 12 months post-activation
Plan to share: No — Data will be stored securely and used only for approved analyses; summary results will be published.
Started Sep 2025 (actual). Primary completion is estimated for Dec 2028, 39 months after the start.
Of 27 observational studies under Dystonia, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 58 and three quarters within 188. This study's planned 39 months is below that.
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Newcastle-upon-Tyne Hospitals NHS Trust