Local Field Potentials in Dystonia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNewcastle-upon-Tyne Hospitals NHS Trust
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Deep Brain Stimulation System
DeviceThe 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.
Treatment groups
25 Participants
are divided into 3 treatment groupsGroup A: Cohort 1 (Pilot group)1 intervention
Group B: Cohort 2 (Main observational group)1 intervention
Group C: Cohort 3 (Exploratory programming group)1 intervention
Trial outcomes
Primary outcomes
1
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 activationSecondary outcomes
1
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 months2
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-activation3
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-activationSponsors and contacts
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Source ClinicalTrials.gov