DystoniaLFP-DYTNCT07309133
Local Field Potentials in Dystonia
An observational study of Dystonia and Dystonia, Focal, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dystonia, Dystonia, Focal, Dystonia, Primary
- What is being tested?
- Deep Brain Stimulation System
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Sep 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Ageing Research Unit,
Newcastle upon Tyne, Tyne & Wear, NE4 6BE
David Ledingham, MA, MBBS, +441912336161, david.ledingham1@nhs.net
David Ledingham, MA, MBBS
About this study
Official title: Optimising Deep Brain Stimulation for Dystonia Using Local Field Potentials
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:
Read more
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.
Read the detailed description
Dystonia is a disabling movement disorder characterized by sustained or intermittent muscle contractions that cause abnormal postures and movements. Deep brain stimulation (DBS) of the globus pallidus interna (GPi) is an established treatment for patients who do not respond adequately to first-line therapies such as botulinum toxin. However, clinical response to DBS in dystonia is highly variable, and optimization of stimulation settings often requires months of trial and error. This delay can prolong disability and increase healthcare burden.
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
- Dystonia, Dystonia, Focal, Dystonia, Primary
- Being tested
- Deep Brain Stimulation System
- Keywords
- Deep Brain Stimulation, DBS, Globus Pallidus Interna, Local Field Potentials, Neurostimulation, Neurophysiology
- Medical subject headings
- Dystonia, Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Deep Brain Stimulation System | |
| 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. Receives: Device: Deep Brain Stimulation System | |
| 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. Receives: Device: Deep Brain Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (pre-activation) up to 1 year post-DBS activation
Secondary outcomes (3)
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.
Measured: Activation visit and follow-up visits up to 12 months
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.
Measured: Baseline and follow-up to 12 months post-activation
Association between LFP changes and clinical improvement
Investigate whether suppression or modulation of LFP peaks correlates with improvement in dystonia severity scores.
Measured: Baseline and follow-up until 12 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start4 Sep 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Dystonia Europe
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309133
- Sponsor's protocol ID
- 10878 - LFPDYT
- Other IDs
- 1982, 10878
- Acronym
- LFP-DYT
- Status last verified
- Nov 2025
- First submitted
- 15 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be stored securely and used only for approved analyses; summary results will be published.
Publications
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.
PubMed 40470846Ledingham 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
Ledingham D, Mills R, Gibbs M, Maynes M, Pal A, Iredale R, Foster V, Ong S, Sathyanarayana S, Jenkins A, Nicholson C, Hussain M, Baker MR, Pavese N. Prospective multi-phase observational study evaluating local field potentials to guide deep brain stimulation programming in dystonia at a UK Tertiary Neurosciences Centre (LFP-DYT): a protocol. BMJ Open. 2026 May 7;16(5):e117391. doi: 10.1136/bmjopen-2026-117391.
PubMed 42097654
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Deep Brain Stimulation for Dystonia Using Local Field Potentials
- ClinicalTrials.gov ID
- NCT07309133
- Acronym / sponsor ID
- LFP-DYT / 10878 - LFPDYT
- Conditions
- Dystonia, Dystonia, Focal, Dystonia, Primary
- Keywords
- Deep Brain Stimulation, DBS, Globus Pallidus Interna, Local Field Potentials, Neurostimulation, Neurophysiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Medtronic, Dystonia Europe
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dystonia is a disabling movement disorder characterized by sustained or intermittent muscle contractions that cause abnormal postures and movements. Deep brain stimulation (DBS) of the globus pallidus interna (GPi) is an established treatment for patients who do not respond adequately to first-line therapies such as botulinum toxin. However, clinical response to DBS in dystonia is highly variable, and optimization of stimulation settings often requires months of trial and error. This delay can prolong disability and increase healthcare burden.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Pilot group) | – | Device: Deep Brain Stimulation SystemDescription: 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) | – | Device: Deep Brain Stimulation SystemDescription: 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) | – | Device: Deep Brain Stimulation SystemDescription: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulation SystemThe 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. | Device | Cohort 1 (Pilot group), Cohort 2 (Main observational group), Cohort 3 (Exploratory programming group) |
Primary outcome
Correlation between GPi LFP peak characteristics and dystonia severity
Time frame: Baseline (pre-activation) up to 1 year post-DBS activation
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).
3 secondary outcomes
Change in LFP peak amplitude with DBS stimulation
Time frame: Activation visit and follow-up visits up to 12 months
Relationship between LFP peak location and optimal stimulation contact
Time frame: Baseline and follow-up to 12 months post-activation
Association between LFP changes and clinical improvement
Time frame: Baseline and follow-up until 12 months post-activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 40470846Ledingham 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.
- BackgroundLedingham 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
- Derived from this study: PubMed 42097654Ledingham D, Mills R, Gibbs M, Maynes M, Pal A, Iredale R, Foster V, Ong S, Sathyanarayana S, Jenkins A, Nicholson C, Hussain M, Baker MR, Pavese N. Prospective multi-phase observational study evaluating local field potentials to guide deep brain stimulation programming in dystonia at a UK Tertiary Neurosciences Centre (LFP-DYT): a protocol. BMJ Open. 2026 May 7;16(5):e117391. doi: 10.1136/bmjopen-2026-117391.
- Individual participant dataSharing planned: No. Data will be stored securely and used only for approved analyses; summary results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonia and Dystonia, Focal, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Ledingham, MA, MBBS (+441912826161, david.ledingham1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between GPi LFP peak characteristics and dystonia severity (time frame: Baseline (pre-activation) up to 1 year post-DBS activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07309133, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.