DystoniaPhase 1NCT02982304
Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
A Phase 1 study testing Deep Brain Stimulation in people with Dystonia and Dystonia, Secondary, run by University of British Columbia at 1 site in Canada.
Trial summary
Dystonia is increasingly being considered as a multi-nodal network disorder involving both basal ganglia and cerebellar dysfunction. The aim of this study is to determine if "Multi-Target" Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients who are receiving inadequate therapy from GPi DBS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dystonia, Dystonia, Secondary
- 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
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Dec 2021
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with hemi-dystonia secondary to stroke
- Candidate for GPi DBS
- Able to provide informed consent
Who cannot join
- History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.
- History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).
- Incompetent adults or those unable to communicate.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Christopher R Honey, MD, DPhil, 604.875.5894, chris.honey@telus.net
About this study
Dystonia is increasingly being considered as a multi-nodal network disorder involving both basal ganglia and cerebellar dysfunction. The aim of this study is to determine if "Multi-Target" Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients who are receiving inadequate therapy from GPi DBS.
- Conditions
- Dystonia, Dystonia, Secondary
- Being tested
- Deep Brain Stimulation
- 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 StimulationDevice
Deep Brain Stimulation Electrode
| Study group | Role | What they receive |
|---|---|---|
| Pallidal (GPi) Deep Brain Stimulation | Active comparator | GPi is the standard target for treating most dystonia. This setting will be the active comparator Receives: Device: Deep Brain Stimulation |
| Thalamic (Vim) Deep Brain Stimulation | Experimental | Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia Receives: Device: Deep Brain Stimulation |
| GPi + Vim (Multi-Target) Deep Brain Stimulation | Experimental | Combined stimulation of GPi and Vim stimulation (both electrodes ON) Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burke Fahn Marsden Disability Rating Scale (BFMDRS)
Measured: 3 months
SF-36 Quality of Life Scale
Measured: 3 months
Adverse effects of Vim or Vim + GPi Neuromodulation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 British ColumbiaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Honey, University of British Columbia
- Investigators
- Chris Honey, MD,DPhil,FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982304
- Sponsor's protocol ID
- H14-03185
- Status last verified
- Oct 2020
- First submitted
- 14 Nov 2016
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Slotty PJ, Poologaindran A, Honey CR. A prospective, randomized, blinded assessment of multitarget thalamic and pallidal deep brain stimulation in a case of hemidystonia. Clin Neurol Neurosurg. 2015 Nov;138:16-9. doi: 10.1016/j.clineuro.2015.07.012. Epub 2015 Jul 29.
PubMed 26241157Prudente CN, Hess EJ, Jinnah HA. Dystonia as a network disorder: what is the role of the cerebellum? Neuroscience. 2014 Feb 28;260:23-35. doi: 10.1016/j.neuroscience.2013.11.062. Epub 2013 Dec 11.
PubMed 24333801
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
- ClinicalTrials.gov ID
- NCT02982304
- Acronym / sponsor ID
- H14-03185
- Conditions
- Dystonia, Dystonia, Secondary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Dec 2016 (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.
Dystonia is increasingly being considered as a multi-nodal network disorder involving both basal ganglia and cerebellar dysfunction. The aim of this study is to determine if "Multi-Target" Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients who are receiving inadequate therapy from GPi DBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pallidal (GPi) Deep Brain Stimulation | Active comparator | Device: Deep Brain StimulationGPi is the standard target for treating most dystonia. This setting will be the active comparator |
| Thalamic (Vim) Deep Brain Stimulation | Experimental | Device: Deep Brain StimulationVim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia |
| GPi + Vim (Multi-Target) Deep Brain Stimulation | Experimental | Device: Deep Brain StimulationCombined stimulation of GPi and Vim stimulation (both electrodes ON) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with hemi-dystonia secondary to stroke
- Candidate for GPi DBS
- Able to provide informed consent
Key exclusion criteria (3 listed)
- History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.
- History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).
- Incompetent adults or those unable to communicate.
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 StimulationDeep Brain Stimulation Electrode | Device | GPi + Vim (Multi-Target) Deep Brain Stimulation, Pallidal (GPi) Deep Brain Stimulation, Thalamic (Vim) Deep Brain Stimulation |
Primary outcome
Burke Fahn Marsden Disability Rating Scale (BFMDRS)
Time frame: 3 months
SF-36 Quality of Life Scale
Time frame: 3 months
Adverse effects of Vim or Vim + GPi Neuromodulation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Background: PubMed 26241157Slotty PJ, Poologaindran A, Honey CR. A prospective, randomized, blinded assessment of multitarget thalamic and pallidal deep brain stimulation in a case of hemidystonia. Clin Neurol Neurosurg. 2015 Nov;138:16-9. doi: 10.1016/j.clineuro.2015.07.012. Epub 2015 Jul 29.
- Background: PubMed 24333801Prudente CN, Hess EJ, Jinnah HA. Dystonia as a network disorder: what is the role of the cerebellum? Neuroscience. 2014 Feb 28;260:23-35. doi: 10.1016/j.neuroscience.2013.11.062. Epub 2013 Dec 11.
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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.
Chris Honey, MD,DPhil,FRCSC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deep Brain Stimulation in people with Dystonia and Dystonia, Secondary, run by University of British Columbia at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 2 Nov 2020. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chris Honey, MD,DPhil,FRCSC (604-875-5894, chris.honey@telus.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burke Fahn Marsden Disability Rating Scale (BFMDRS) (time frame: 3 months). The study lists 3 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 NCT02982304, which also lists 2 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 2 Nov 2020.