Using GPi brain signals to guide DBS programming for primary dystonia
Optimising Deep Brain Stimulation for Dystonia Using Local Field Potentials
Newcastle-upon-Tyne Hospitals NHS Trust · NCT07309133
This study will test whether recording local field potentials from the globus pallidus interna with the Medtronic Percept device can help guide DBS programming and improve symptoms in adults with primary dystonia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Newcastle-upon-Tyne Hospitals NHS Trust (other) |
| Locations | 1 site (Newcastle upon Tyne, Tyne & Wear) |
| Trial ID | NCT07309133 on ClinicalTrials.gov |
What this trial studies
This single-site, prospective observational study will enroll adults with primary dystonia who are candidates for GPi DBS and implant the Medtronic Percept device to record chronic local field potentials. The protocol includes an internal pilot and two main cohorts comparing traditional programming based on clinical assessment and imaging with programming guided by LFP peak characteristics. Investigators will examine whether alpha–theta LFP peaks correlate with dystonia severity, how LFP profiles change with stimulation, botulinum toxin, or medications, and whether LFP-guided settings produce similar or better clinical outcomes. Clinical severity measures and continuous LFP recordings from implanted GPi electrodes will be collected over follow-up for comparison.
Who should consider this trial
Good fit: Adults (≥18) with a clinical diagnosis of primary (idiopathic or genetic) dystonia who are candidates for GPi DBS and able to give informed consent.
Not a fit: Patients with secondary or functional dystonia, significant cognitive or psychiatric disorders, or recent participation in other therapeutic trials are excluded and therefore unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, LFP-guided programming could shorten the time to optimal DBS settings and improve symptom control for people with dystonia.
How similar studies have performed: LFP-guided approaches have shown utility in Parkinson's disease and small short-term dystonia recordings suggest low-frequency peaks may be informative, but chronic GPi sensing to guide programming in dystonia is still novel and unproven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Newcastle upon Tyne, Tyne & Wear
- Clinical Ageing Research Unit, — Newcastle upon Tyne, Tyne & Wear, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: David Ledingham, MA, MBBS
- Email: david.ledingham1@nhs.net
- Phone: +441912826161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dystonia, Dystonia, Focal, Dystonia, Primary, Deep Brain Stimulation, DBS, Globus Pallidus Interna, Local Field Potentials, Neurostimulation