Cervical DystoniaNCT00132990
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
A study testing Deep brain stimulation in people with Cervical Dystonia, run by University of Calgary at 5 sites in Canada.
Trial summary
The purposes of this study are: to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements; to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and to document the adverse effects of surgery in patients with cervical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 5 sitesCanada
- Study dates
- Feb 2003to Sep 2005
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, male or female
- Diagnosed with cervical dystonia by a movement disorders neurologist
- Has cervical dystonia alone, not generalized or multifocal
- Has had adequate trials of medical therapy
Who cannot join
- Cognitive impairment
- Abnormalities on pre-operative magnetic resonance imaging (MRI)
- Medical conditions precluding general anaesthetic or surgery
- Unstable psychiatric disease
- Previous brain lesions to treat cervical dystonia
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Dr. Zelma Kiss
Calgary, Alberta, T2N 4N1
Dr. Matt Wheatley
Edmonton, Alberta, T2G 2B7
Dr. Andrew Parrent
London, Ontario, N6A 5A5
Dr. Chris Honey
Vancouver, British Columbia, V5Z 4E5
Dr. Jerry Krcek
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
The purposes of this study are:
- to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements;
- to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and
- to document the adverse effects of surgery in patients with cervical dystonia.
Read the detailed description
Deep brain stimulation (DBS) of the globus pallidus has been proposed as a treatment for cervical dystonia. At present there are only anecdotal reports of benefit. The objective of this project is to prospectively assess the outcomes of DBS on cervical dystonia in a blinded manner. Our hypothesis is that in patients refractory to medical management, bilateral pallidal DBS will reduce the severity of cervical dystonia at 1 year follow up.
The research plan is that of a feasibility study, examining outcomes of 10 patients who would be referred for surgical management due to the severity of their disease. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) will be preformed by a blinded neurologist at the completion of the trial.
- Conditions
- Cervical Dystonia
- Being tested
- Deep brain stimulation
- Keywords
- Cervical dystonia, Deep brain stimulation
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in neck postures/movements
Improvement in quality of life
Secondary outcomes (1)
Document adverse effects of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startFeb 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Calgary Health Region, Medtronic
- Investigators
- Zelma Kiss, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132990
- Sponsor's protocol ID
- 16760
- Status last verified
- Jan 2007
- First submitted
- 18 Aug 2005
- Last updated
- 20 May 2019
- Results posted
- No
Publications
Kiss ZH, Doig-Beyaert K, Eliasziw M, Tsui J, Haffenden A, Suchowersky O; Functional and Stereotactic Section of the Canadian Neurosurgical Society; Canadian Movement Disorders Group. The Canadian multicentre study of deep brain stimulation for cervical dystonia. Brain. 2007 Nov;130(Pt 11):2879-86. doi: 10.1093/brain/awm229. Epub 2007 Sep 28.
PubMed 17905796
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia
- ClinicalTrials.gov ID
- NCT00132990
- Acronym / sponsor ID
- 16760
- Conditions
- Cervical Dystonia
- Keywords
- Cervical dystonia, Deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Calgary Health Region, Medtronic
- Study start
- Feb 2003
- Study completion
- Sep 2005 (actual)
- First posted
- 22 Aug 2005 (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.
The purposes of this study are:
- to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements;
- to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and
- to document the adverse effects of surgery in patients with cervical dystonia.
Detailed description
Deep brain stimulation (DBS) of the globus pallidus has been proposed as a treatment for cervical dystonia. At present there are only anecdotal reports of benefit. The objective of this project is to prospectively assess the outcomes of DBS on cervical dystonia in a blinded manner. Our hypothesis is that in patients refractory to medical management, bilateral pallidal DBS will reduce the severity of cervical dystonia at 1 year follow up.
The research plan is that of a feasibility study, examining outcomes of 10 patients who would be referred for surgical management due to the severity of their disease. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) will be preformed by a blinded neurologist at the completion of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, male or female
- Diagnosed with cervical dystonia by a movement disorders neurologist
- Has cervical dystonia alone, not generalized or multifocal
- Has had adequate trials of medical therapy
Key exclusion criteria (5 listed)
- Cognitive impairment
- Abnormalities on pre-operative magnetic resonance imaging (MRI)
- Medical conditions precluding general anaesthetic or surgery
- Unstable psychiatric disease
- Previous brain lesions to treat cervical 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 | Device | – |
Primary outcome
Improvement in neck postures/movements
Improvement in quality of life
1 secondary outcome
Document adverse effects of surgery
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 20 May 2019.
- Derived from this study: PubMed 17905796Kiss ZH, Doig-Beyaert K, Eliasziw M, Tsui J, Haffenden A, Suchowersky O; Functional and Stereotactic Section of the Canadian Neurosurgical Society; Canadian Movement Disorders Group. The Canadian multicentre study of deep brain stimulation for cervical dystonia. Brain. 2007 Nov;130(Pt 11):2879-86. doi: 10.1093/brain/awm229. Epub 2007 Sep 28.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Zelma Kiss, MD principal investigator
University of Calgary
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Cervical Dystonia, run by University of Calgary at 5 sites in Canada.
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 5 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 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
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?
Improvement in neck postures/movements. The study lists 2 primary outcomes in all. 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 NCT00132990, 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 20 May 2019.