| NCT ID | NCT07309133 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Newcastle-upon-Tyne Hospitals NHS Trust |
| Condition | Dystonia |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2025-09-04 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07309133 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07309133 currently recruiting?
Yes, NCT07309133 is actively recruiting participants. Contact the research team at david.ledingham1@nhs.net for enrollment information.
Where is the NCT07309133 trial being conducted?
This trial is being conducted at Newcastle upon Tyne, United Kingdom.
Who is sponsoring the NCT07309133 clinical trial?
NCT07309133 is sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. The trial plans to enroll 25 participants.