Parkinson's DiseasePhase 2NCT03417271
Short Pulse Width DBS in Parkinson's Disease
A Phase 2 study testing Deep brain stimulation in people with Parkinson's Disease, run by University College, London at 1 site in United Kingdom.
Trial summary
The aim of this investigation is to explore the effect of reducing conventional pulse width of stimulation on known adverse effects of Subthalamic nucleus Deep Brain Stimulation (STN DBS) treatment such as; slurring of speech, gait impairment, and unsteadiness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2018to 24 Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease - PD is a clinical diagnosis and is based on the opinion of the PI on site after review of the clinical history, examination findings and response to PD medication. The Queen Square brain bank criteria MAY be used to help assist in the diagnosis although this need not be a formal inclusion criteria, and the relevance of a positive family history of PD, or a confirmed genetic basis for an individual's symptoms will be evaluated in the context of other clinical features in determining diagnosis and eligibility.
- Male or Female.
- Treatment with subthalamic deep brain stimulation using Medtronic Activa PC hardware for at least 12 months.
- Experiencing stimulation-induced slurring of speech defined as scoring 50-80% speech intelligibility on the Assessment of Intelligibility of Speech scale.
- All patients will be ≥ 25 and ≤ 75 years of age.
- Documented informed consent to participate.
Who cannot join
- Patients unable to provide documented informed consent.
- Already actively participating in an investigation of a drug, device or surgical treatment for Parkinson's disease.
- Potential participants who lack the capacity to give informed consent.
- Any medical, psychiatric or other condition which in the investigator's opinion compromises the potential participant's ability to participate fully.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized Crossover Comparison of Short Pulse Width Versus Conventional Pulse Width Deep Brain Stimulation (DBS) in Parkinson's Disease Patients With Previously Implanted DBS Systems- a Pilot Trial
The aim of this investigation is to explore the effect of reducing conventional pulse width of stimulation on known adverse effects of Subthalamic nucleus Deep Brain Stimulation (STN DBS) treatment such as; slurring of speech, gait impairment, and unsteadiness. This investigation is designed such that each of 16 patients (who have all had chronically implanted DBS systems), will be assessed using conventional (DBS-60µs) and short (DBS-30µs) pulse width DBS, in a randomised order.
Read the detailed description
Conventional DBS most commonly uses 60µs pulse width stimulation. Higher pulse widths are less well tolerated by patients as a result of adverse effects. The ability to use short pulse width (30µs) DBS in chronically implanted STN-DBS patients has been made possible as a result of the provision of a novel software flashcard (8870 XBP application card) developed by Medtronic, compatible with the routine Medtronic N'Vision 8870 Clinician Programmer. The Medtronic 8870-XBP flashcard will enable shorter pulse width (30µs) to be used with previously implanted conventional Medtronic DBS hardware, however this is not licensed at present.
The aim of this clinical investigation is to confirm the longevity of response and the clinical relevance of DBS-30µs versus DBS-60µs in DBS patients using "optimized" stimulation amplitudes for each pulse-width. This project will be conducted in patients with Parkinson's disease who have had long term bilateral sub thalamic nucleus Deep Brain Stimulation implants. As such, they will be regular attenders at the Unit of Functional Neurosurgery, National Hospital for Neurology \& Neurosurgery, and will have had frequent previous attempts at adjusting their DBS parameters including overnight stays, and off- medication assessments to optimize motor function and minimize adverse effects. They will be familiar with all procedures to be used in this study. They will be aware that the objective of the study is to identify whether additional improvements in dysarthric speech can be achieved by the use of a short pulse width setting and therefore will be highly motivated to participate.
This investigation is designed such that each patient will be assessed under the DBS-30µs and DBS-60µs pulse width condition, in a randomised order. The patients and rating clinicians will be blinded to randomisation order. An unblinded clinician will be responsible for programming the stimulation. The use of a crossover design allows each patient to essentially act as their own control subject, and will maximise the ability to judge using paired statistical tests whether there is a consistent advantage in speech intelligibility using the shorter pulse width (DBS-30µs).
- Conditions
- Parkinson's Disease
- Being tested
- Deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
The different stimulation pulse widths are made possible by the use of a Medtronic XBP flashcard used with the conventional Medtronic 8840 programmer.
| Study group | Role | What they receive |
|---|---|---|
| 30us stimulation then 60us stimulation | Active comparator | All patients will receive both types of stimulation in a randomised crossover design. This arm will receive 30us stimulation for 4 weeks then will be switched to 60us stimulation for 4 weeks. Receives: Device: Deep brain stimulation |
| 60us stimulation then 30us stimulation | Active comparator | All patients will receive both types of stimulation in a randomised crossover design.This arm will receive 60us stimulation for 4 weeks then will be switched to 30us stimulation for 4 weeks. Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility test
Percentage of intelligible words spoken during formal speech assessment
Measured: 4 weeks
Secondary outcomes (4)
Movement Disorders Society Unified Parkinson's Disease Rating Scale
Validated movement scale for Parkinson's disease. Range 0-132. Higher scores indicate worse disability.
Measured: 4 weeks
Dyskinesia Rating Scale
Validated dyskinesia rating scale. Range 0-104. Higher scores indicate worse disability.
Measured: 4 weeks
Verbal Fluency
Number of words produced in 1 minute
Measured: 4 weeks
Timed Motor tests
Walking and hand tapping
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start2 May 2018
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Foltynie, MRCP PhD, Principal investigator, UCL Institute of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417271
- Sponsor's protocol ID
- 16/0772
- Status last verified
- Apr 2019
- First submitted
- 17 Jan 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Crossover Comparison of Short Pulse Width Versus Conventional Pulse Width Deep Brain Stimulation (DBS) in Parkinson's Disease Patients With Previously Implanted DBS Systems- a Pilot Trial
- ClinicalTrials.gov ID
- NCT03417271
- Acronym / sponsor ID
- 16/0772
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 31 Jan 2018 (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 aim of this investigation is to explore the effect of reducing conventional pulse width of stimulation on known adverse effects of Subthalamic nucleus Deep Brain Stimulation (STN DBS) treatment such as; slurring of speech, gait impairment, and unsteadiness. This investigation is designed such that each of 16 patients (who have all had chronically implanted DBS systems), will be assessed using conventional (DBS-60µs) and short (DBS-30µs) pulse width DBS, in a randomised order.
Detailed description
Conventional DBS most commonly uses 60µs pulse width stimulation. Higher pulse widths are less well tolerated by patients as a result of adverse effects. The ability to use short pulse width (30µs) DBS in chronically implanted STN-DBS patients has been made possible as a result of the provision of a novel software flashcard (8870 XBP application card) developed by Medtronic, compatible with the routine Medtronic N'Vision 8870 Clinician Programmer. The Medtronic 8870-XBP flashcard will enable shorter pulse width (30µs) to be used with previously implanted conventional Medtronic DBS hardware, however this is not licensed at present.
The aim of this clinical investigation is to confirm the longevity of response and the clinical relevance of DBS-30µs versus DBS-60µs in DBS patients using "optimized" stimulation amplitudes for each pulse-width. This project will be conducted in patients with Parkinson's disease who have had long term bilateral sub thalamic nucleus Deep Brain Stimulation implants. As such, they will be regular attenders at the Unit of Functional Neurosurgery, National Hospital for Neurology \& Neurosurgery, and will have had frequent previous attempts at adjusting their DBS parameters including overnight stays, and off- medication assessments to optimize motor function and minimize adverse effects. They will be familiar with all procedures to be used in this study. They will be aware that the objective of the study is to identify whether additional improvements in dysarthric speech can be achieved by the use of a short pulse width setting and therefore will be highly motivated to participate.
This investigation is designed such that each patient will be assessed under the DBS-30µs and DBS-60µs pulse width condition, in a randomised order. The patients and rating clinicians will be blinded to randomisation order. An unblinded clinician will be responsible for programming the stimulation. The use of a crossover design allows each patient to essentially act as their own control subject, and will maximise the ability to judge using paired statistical tests whether there is a consistent advantage in speech intelligibility using the shorter pulse width (DBS-30µs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30us stimulation then 60us stimulation | Active comparator | Device: Deep brain stimulationAll patients will receive both types of stimulation in a randomised crossover design. This arm will receive 30us stimulation for 4 weeks then will be switched to 60us stimulation for 4 weeks. |
| 60us stimulation then 30us stimulation | Active comparator | Device: Deep brain stimulationAll patients will receive both types of stimulation in a randomised crossover design.This arm will receive 60us stimulation for 4 weeks then will be switched to 30us stimulation for 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Parkinson's disease - PD is a clinical diagnosis and is based on the opinion of the PI on site after review of the clinical history, examination findings and response to PD medication. The Queen Square brain bank criteria MAY be used to help assist in the diagnosis although this need not be a formal inclusion criteria, and the relevance of a positive family history of PD, or a confirmed genetic basis for an individual's symptoms will be evaluated in the context of other clinical features in determining diagnosis and eligibility.
- Male or Female.
- Treatment with subthalamic deep brain stimulation using Medtronic Activa PC hardware for at least 12 months.
- Experiencing stimulation-induced slurring of speech defined as scoring 50-80% speech intelligibility on the Assessment of Intelligibility of Speech scale.
- All patients will be ≥ 25 and ≤ 75 years of age.
Key exclusion criteria (4 listed)
- Patients unable to provide documented informed consent.
- Already actively participating in an investigation of a drug, device or surgical treatment for Parkinson's disease.
- Potential participants who lack the capacity to give informed consent.
- Any medical, psychiatric or other condition which in the investigator's opinion compromises the potential participant's ability to participate fully.
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 stimulationThe different stimulation pulse widths are made possible by the use of a Medtronic XBP flashcard used with the conventional Medtronic 8840 programmer. | Device | 30us stimulation then 60us stimulation, 60us stimulation then 30us stimulation |
Primary outcome
Speech Intelligibility test
Time frame: 4 weeks
Percentage of intelligible words spoken during formal speech assessment
4 secondary outcomes
Movement Disorders Society Unified Parkinson's Disease Rating Scale
Time frame: 4 weeks
Dyskinesia Rating Scale
Time frame: 4 weeks
Verbal Fluency
Time frame: 4 weeks
Timed Motor tests
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thomas Foltynie, MRCP PhD principal investigator
UCL Institute of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deep brain stimulation in people with Parkinson's Disease, run by University College, London 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 17 Apr 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Intelligibility test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2019.