Deep Brain Stimulation Clinical Trials

Clinical trials related to Deep Brain Stimulation Procedure

Optimising Deep Brain Stimulation for Dystonia Using Local Field Potentials

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Clinical Ageing Research Unit,
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
David Ledingham, MA, MBBS
david.ledingham1@nhs.net
+441912826161
Time Frame
Start Date: 2025-09-04
Estimated Completion Date: 2028-12
Participants
Target number of participants: 25
Treatments
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.
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.
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.
Sponsors
Collaborators: Medtronic, Dystonia Europe
Leads: Newcastle-upon-Tyne Hospitals NHS Trust

This content was sourced from clinicaltrials.gov