Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
25 participants
OBSERVATIONAL
2025-09-04
2028-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Participation in a therapeutic research trial within the last year.
* Diagnosis of functional (psychogenic) dystonia.
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Dystonia Europe
UNKNOWN
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Responsible Party
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Locations
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Clinical Ageing Research Unit,
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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David Ledingham, MA, MBBS
Role: primary
References
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Ledingham D, Gibbs M, Mills R, Jenkins A, Nicholson C, Hussain MA, Baker M, Pavese N. Decoding Cervical Dystonia: Insights from Local Field Potentials in a Case Study Utilizing Open-Source Toolboxes. Mov Disord Clin Pract. 2025 Oct;12(10):1675-1678. doi: 10.1002/mdc3.70164. Epub 2025 Jun 5. No abstract available.
Ledingham D, Baker M, Pavese N. Local field potentials: Therapeutic implications for DBS in dystonia including adaptive DBS for dystonia. Deep Brain Stimulation. 2024;5:4-19. doi:10.1016/j.jdbs.2024.03.003
Other Identifiers
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1982
Identifier Type: OTHER
Identifier Source: secondary_id
10878
Identifier Type: OTHER
Identifier Source: secondary_id
10878 - LFPDYT
Identifier Type: -
Identifier Source: org_study_id