DystoniaSTN DBSNCT00773604
Deep Brain Stimulation in Patients With Dystonia
A study testing Medtronic implantable deep brain stimulation (DBS) system in people with Dystonia, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia. Read more about this study
- Who is it for?
- Ages 7 to 80 years
- Conditions the study is for
- Dystonia
- What is being tested?
- Medtronic implantable deep brain stimulation (DBS) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Refractory primary dystonia diagnosed by a movement disorders neurologist
- Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
- Age 7-80 years (UCSF patients) and 18-80 (VA patients)
Who cannot join
- Patients considered at high risk for elective neurosurgery because of co-morbid conditions
- Brain MRI showing extensive brain atrophy or small vessel ischemic disease
- Pregnancy
- Inability to tolerate awake microelectrode-guided neurosurgery
- Inability to follow up with post-operative study visits
- Inability to speak or read English
- Patients with a score of 4.5 or lower on the BFMDRS movement scale
- Patients with Secondary dystonia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco Veterans Administration Medical Center
San Francisco, California, 94121
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) in Patients With Dystonia
The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.
Read the detailed description
Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing twisting, writhing movements and abnormal postures. It is associated with abnormal electrical activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi) and the subthalamic nucleus (STN). Deep brain stimulation (DBS) has been shown to be an effective treatment in patients with medically refractory dystonia and is currently approved for both the GPi and STN targets under a humanitarian device exemption (HDE) for use in segmental and generalized primary dystonia as well as focal cervical dystonia. GPi DBS appears to be effective for medication-refractory focal and segmental dystonia affecting the cranial and cervical regions in open-label series, but recently GPi stimulation has been associated with subtle motor disturbances in previously non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the STN has also been reported to be effective for treating generalized and cervical dystonia in small open label trials. STN DBS for cranial and cervical regions may provide similar efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced motor effects. Objectives of this study are to evaluate the safety and efficacy of STN DBS for dystonia. Up to twenty-five patients will be screened, consented, and enrolled in this study. All patients will undergo bilateral STN DBS for dystonia. Participants will be evaluated pre- and postoperatively with standard dystonia rating scale Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), and a patient questionnaire will be administered postoperatively to determine if patients are experiencing stimulation-induced motor adverse effects and will be logged for safety monitoring. This pilot study will provide preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and will help determine if this target should be compared to GPi DBS in a larger double-blind trial.
- Conditions
- Dystonia
- Being tested
- Medtronic implantable deep brain stimulation (DBS) system
- Keywords
- blepharospasm, Deep brain Stimulation, cervical dystonia, cranial dystonia, generalized dystonia, subthalamic nucleus, DBS
- Medical subject headings
- Dystonia, Blepharospasm, Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic implantable deep brain stimulation (DBS) systemDevice
surgical placement of deep brain stimulation system for treatment of dystonia
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Deep Brain Stimulation Receives: Device: Medtronic implantable deep brain stimulation (DBS) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Toronto Western Spasmodic Rating Scale (TWSTRS) Movement Scores Measured Before DBS Surgery (Baseline) and at 12 Months
Total TWSTRS score range is 0-88, where higher score indicates worse symptoms. Values are calculated by baseline minus 12 month, where higher difference score of change between baseline and 12 months means better outcome (more improvement)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill Ostrem, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773604
- Sponsor's protocol ID
- Private donor
- Acronym
- STN DBS
- Status last verified
- Feb 2019
- First submitted
- 7 Oct 2008
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data may be shared with research collaborators.
Publications
Ostrem JL, San Luciano M, Dodenhoff KA, Ziman N, Markun LC, Racine CA, de Hemptinne C, Volz MM, Heath SL, Starr PA. Subthalamic nucleus deep brain stimulation in isolated dystonia: A 3-year follow-up study. Neurology. 2017 Jan 3;88(1):25-35. doi: 10.1212/WNL.0000000000003451. Epub 2016 Nov 30.
PubMed 27903810
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) in Patients With Dystonia
- ClinicalTrials.gov ID
- NCT00773604
- Acronym / sponsor ID
- STN DBS / Private donor
- Conditions
- Dystonia
- Keywords
- blepharospasm, Deep brain Stimulation, cervical dystonia, cranial dystonia, generalized dystonia, subthalamic nucleus, DBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.
Detailed description
Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing twisting, writhing movements and abnormal postures. It is associated with abnormal electrical activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi) and the subthalamic nucleus (STN). Deep brain stimulation (DBS) has been shown to be an effective treatment in patients with medically refractory dystonia and is currently approved for both the GPi and STN targets under a humanitarian device exemption (HDE) for use in segmental and generalized primary dystonia as well as focal cervical dystonia. GPi DBS appears to be effective for medication-refractory focal and segmental dystonia affecting the cranial and cervical regions in open-label series, but recently GPi stimulation has been associated with subtle motor disturbances in previously non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the STN has also been reported to be effective for treating generalized and cervical dystonia in small open label trials. STN DBS for cranial and cervical regions may provide similar efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced motor effects. Objectives of this study are to evaluate the safety and efficacy of STN DBS for dystonia. Up to twenty-five patients will be screened, consented, and enrolled in this study. All patients will undergo bilateral STN DBS for dystonia. Participants will be evaluated pre- and postoperatively with standard dystonia rating scale Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), and a patient questionnaire will be administered postoperatively to determine if patients are experiencing stimulation-induced motor adverse effects and will be logged for safety monitoring. This pilot study will provide preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and will help determine if this target should be compared to GPi DBS in a larger double-blind trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: Medtronic implantable deep brain stimulation (DBS) systemDeep Brain Stimulation |
Who may qualify
- Ages
- 7 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Refractory primary dystonia diagnosed by a movement disorders neurologist
- Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
- Age 7-80 years (UCSF patients) and 18-80 (VA patients)
Key exclusion criteria (8 listed)
- Patients considered at high risk for elective neurosurgery because of co-morbid conditions
- Brain MRI showing extensive brain atrophy or small vessel ischemic disease
- Pregnancy
- Inability to tolerate awake microelectrode-guided neurosurgery
- Inability to follow up with post-operative study visits
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 |
|---|---|---|
| Medtronic implantable deep brain stimulation (DBS) systemsurgical placement of deep brain stimulation system for treatment of dystonia | Device | Treatment |
Primary outcome
The Toronto Western Spasmodic Rating Scale (TWSTRS) Movement Scores Measured Before DBS Surgery (Baseline) and at 12 Months
Time frame: Baseline and 12 months
Total TWSTRS score range is 0-88, where higher score indicates worse symptoms. Values are calculated by baseline minus 12 month, where higher difference score of change between baseline and 12 months means better outcome (more improvement)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27903810Ostrem JL, San Luciano M, Dodenhoff KA, Ziman N, Markun LC, Racine CA, de Hemptinne C, Volz MM, Heath SL, Starr PA. Subthalamic nucleus deep brain stimulation in isolated dystonia: A 3-year follow-up study. Neurology. 2017 Jan 3;88(1):25-35. doi: 10.1212/WNL.0000000000003451. Epub 2016 Nov 30.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with research collaborators.
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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.
Jill Ostrem, M.D. principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic implantable deep brain stimulation (DBS) system in people with Dystonia, run by University of California, San Francisco at 2 sites in United States.
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 8 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Toronto Western Spasmodic Rating Scale (TWSTRS) Movement Scores Measured Before DBS Surgery (Baseline) and at 12 Months (time frame: Baseline and 12 months). 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 NCT00773604, which also lists 1 linked publication.
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 19 Feb 2019.