DystoniaNCT00971854
Alteration of Deep Brain Stimulation Parameters for Dystonia
A study testing Alteration of deep brain stimulator settings in people with Dystonia, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Deep brain stimulation (DBS) involves placing electrodes into the brain. Through these electrodes, artificial electrical signals are chronically delivered into deep brain regions in order to alter abnormal brain activity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dystonia
- What is being tested?
- Alteration of deep brain stimulator settings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Feb 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary dystonia (focal cervical or generalised dystonia) who are receiving chronic (>1 year) bilateral pallidal stimulation but have had poor therapeutic responses (< 50% improvement in relevant dystonia severity rating scale*) despite confirmation of accurate electrode position.
- Able to understand study requirements - able to provide consent.
- Relevant dystonia rating scales: Cervical dystonia - severity subsection of the Toronto Western Hospital spasmodic torticollis rating scale; Generalised dystonia - severity section of the Burke Fahn Marsden rating scale.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford, Nuffield Department of Surgery
Oxford, Oxfordshire, OX3 9DU
Wesley Thevathasan, MBBS FRACP, 07748729186, wesley.thevathasan@nds.ox.ac.uk
Julian Woollard, MBBS BSc, 07779 654 944, julian.woollard@doctors.org.uk
About this study
Official title: Alteration of Deep Brain Stimulation Parameters for Dystonia- A Double Blinded Randomised Controlled Trial
Deep brain stimulation (DBS) involves placing electrodes into the brain. Through these electrodes, artificial electrical signals are chronically delivered into deep brain regions in order to alter abnormal brain activity. The artificial electrical signals are generated by a battery that is inserted under the skin of the chest. DBS is used to treat several disorders of movement, including dystonia. In dystonia, the electrodes are inserted into a brain region called the globus pallidus.
Globus pallidus stimulation can be very effective therapy for dystonia. However not all patients are equally responsive and therapeutic outcomes can be frustratingly variable. The reason for this variability is unclear. Such variability in response may need to be met by tailoring stimulation to individual patients.
Read more
Another issue with deep brain stimulation is battery life. Eventually, batteries become depleted and need to be replaced. Such battery replacements require an operation, hospital stay and the risk of introducing infection. The high electrical energy that has been used to treat dystonia means that batteries are typically replaced every year or two.
The artificial electrical signals of deep brain stimulation are delivered with three parameters; frequency (Hertz - Hz), voltage (volts) and pulse width (microseconds). It has recently been reported that lower frequency stimulation, at 60Hz rather than 130Hz, can be used effectively to treat dystonia. Such 60Hz stimulation may be more effective for some patients than others. The lower energy demands of 60Hz stimulation would also greatly improve battery life (potentially doubling battery life).
The aim of this study is to assess if 60Hz stimulation is more effective in ameliorating the dystonia of patients who have responded poorly to 130Hz pallidal stimulation. The current status of the evidence is one of clinical equipoise (uncertainty) and therefore suits a double blinded randomised trial.
- Conditions
- Dystonia
- Being tested
- Alteration of deep brain stimulator settings
- Keywords
- Dystonia
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alteration of deep brain stimulator settingsProcedure or surgery
From 130Hz to 60Hz pallidal stimulation
| Study group | Role | What they receive |
|---|---|---|
| 60 Hz stimulation | Experimental | Experimental reduced frequency pallidal stimulation Receives: Procedure: Alteration of deep brain stimulator settings |
| 130 Hz stimulation | No intervention | Current standard pallidal stimulation setting Receives: Procedure: Alteration of deep brain stimulator settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if the stimulation frequency of 60 Hz is superior to 130 Hz for patients with primary dystonia who have responded poorly to standard 130 Hz pallidal stimulation
Measured: 6 months
Secondary outcomes (1)
Assess any potential changes in anxiety, mood, cognition
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Investigators
- Tipu Aziz, Professor, Principal investigator, University of Oxford, Nuffield Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971854
- Sponsor's protocol ID
- 09/H0603/11
- Other IDs
- R&D Study - 5898
- Status last verified
- Sep 2009
- First submitted
- 3 Sep 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration of Deep Brain Stimulation Parameters for Dystonia- A Double Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00971854
- Acronym / sponsor ID
- 09/H0603/11
- Conditions
- Dystonia
- Keywords
- Dystonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 4 Sep 2009 (estimated)
- 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.
Deep brain stimulation (DBS) involves placing electrodes into the brain. Through these electrodes, artificial electrical signals are chronically delivered into deep brain regions in order to alter abnormal brain activity. The artificial electrical signals are generated by a battery that is inserted under the skin of the chest. DBS is used to treat several disorders of movement, including dystonia. In dystonia, the electrodes are inserted into a brain region called the globus pallidus.
Globus pallidus stimulation can be very effective therapy for dystonia. However not all patients are equally responsive and therapeutic outcomes can be frustratingly variable. The reason for this variability is unclear. Such variability in response may need to be met by tailoring stimulation to individual patients.
Another issue with deep brain stimulation is battery life. Eventually, batteries become depleted and need to be replaced. Such battery replacements require an operation, hospital stay and the risk of introducing infection. The high electrical energy that has been used to treat dystonia means that batteries are typically replaced every year or two.
The artificial electrical signals of deep brain stimulation are delivered with three parameters; frequency (Hertz - Hz), voltage (volts) and pulse width (microseconds). It has recently been reported that lower frequency stimulation, at 60Hz rather than 130Hz, can be used effectively to treat dystonia. Such 60Hz stimulation may be more effective for some patients than others. The lower energy demands of 60Hz stimulation would also greatly improve battery life (potentially doubling battery life).
The aim of this study is to assess if 60Hz stimulation is more effective in ameliorating the dystonia of patients who have responded poorly to 130Hz pallidal stimulation. The current status of the evidence is one of clinical equipoise (uncertainty) and therefore suits a double blinded randomised trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60 Hz stimulation | Experimental | Procedure: Alteration of deep brain stimulator settingsExperimental reduced frequency pallidal stimulation |
| 130 Hz stimulation | No intervention | Procedure: Alteration of deep brain stimulator settingsCurrent standard pallidal stimulation setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary dystonia (focal cervical or generalised dystonia) who are receiving chronic (>1 year) bilateral pallidal stimulation but have had poor therapeutic responses (< 50% improvement in relevant dystonia severity rating scale*) despite confirmation of accurate electrode position.
- Able to understand study requirements - able to provide consent.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Alteration of deep brain stimulator settingsFrom 130Hz to 60Hz pallidal stimulation | Procedure or surgery | 130 Hz stimulation, 60 Hz stimulation |
Primary outcome
To assess if the stimulation frequency of 60 Hz is superior to 130 Hz for patients with primary dystonia who have responded poorly to standard 130 Hz pallidal stimulation
Time frame: 6 months
1 secondary outcome
Assess any potential changes in anxiety, mood, cognition
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
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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.
Tipu Aziz, Professor principal investigator
University of Oxford, Nuffield Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alteration of deep brain stimulator settings in people with Dystonia, run by University of Oxford 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Oct 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wesley Thevathasan, MBBS FRACP (07748729186, wesley.thevathasan@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess if the stimulation frequency of 60 Hz is superior to 130 Hz for patients with primary dystonia who have responded poorly to standard 130 Hz pallidal stimulation (time frame: 6 months). 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 14 Oct 2009.