Ataxia, GaitDBS-AtaxiaNCT07427563
Cerebellar Deep Brain Stimulation for the Treatment of Ataxia
A study testing Deep Brain Stimulation in people with Ataxia, Gait, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Abnormal gait is often associated with immobility and falls, which in turn lead to loss of functional independence and death. While gait disorders may arise from many different etiologies, dysfunction of the cerebellum (a part of the brain with the function of coordination of movement) leading to gait disorders… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Ataxia, Gait
- 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
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 2 Mar 2023to 31 Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or Male patients between age 20-70
- Diagnosis of primary ataxia (inclusive of congenital and hereditary subtypes without other neurological compromise)
- Head CT scan and cerebral MRI without any structural contraindications for safe DBS
- Patient able to give written consent
- Able to comply with all testing, follow-ups and study appointments and protocols
Who cannot join
- Active neurologic disease including but not limited to epilepsy and certain brain tumors
- Secondary ataxia (such as due to stroke, medication, autoimmune disease, ischemia, tumor, or other lesion)
- Any contraindication to MRI scanning
- Likely to relocate or move during the study's one-year duration
- Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Altagracia Cantos, 416-603-5866, Altagracia.Cantos@uhn.ca
About this study
Official title: Cerebellar Deep Brain Stimulation for the Treatment of Refractory Ataxia and Gait Disorders: Pilot Trial
Abnormal gait is often associated with immobility and falls, which in turn lead to loss of functional independence and death. While gait disorders may arise from many different etiologies, dysfunction of the cerebellum (a part of the brain with the function of coordination of movement) leading to gait disorders results in distinct features. Gait ataxia is a specific type of neurological gait disorder and is defined as the presence of abnormal, uncoordinated movements associated with gait. To date, there are limited treatments for ataxia and/or gait disorders. Deep brain stimulation (DBS) is a neurosurgical tool that has been widely used for over twenty years, mainly to treat Parkinson's disease, dystonia, and essential tremor. In this study, we aim to implant DBS in patients with ataxia and/or gait disorder in the cerebellum area, and electrically stimulate them in a titratable and ultimately reversible manner. This study is divided into 3 phases: pre-operative, operative and post-operative phase. The purpose of this pilot study is to evaluate the safety, feasibility, and to validate the DBS of cerebellar cortical and deep nuclei in patients with treatment refractory ataxia. Twelve(12 ) patients will be enrolled in this study.
- Conditions
- Ataxia, Gait
- Being tested
- Deep Brain Stimulation
- Keywords
- deep brain stimulation (DBS), cerebellar
- Medical subject headings
- Gait Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Standard of care Neurosugical implantation of Deep Brain Stimulation under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Neurosurgery | Active comparator | Standard of Care Neurosurgery for new indication Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DBS surgical complications defined by the CTCAE (2017)
The overall incidence of surgical complications will be documented and used as a safety parameter. Published complication rates for DBS surgery are between 4% to 30%, with an overall mean of 16% . Therefore, to be considered a safe treatment, incidence should not be higher than 30%. Surgical complication will be defined according to the CTCAE, documenting the cases of grade 2 to 5 (CTCAE, 2017).
Measured: Surgical complication will assessed and recorded at 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP
Secondary outcomes (1)
Improvement in Scale for the Assessment and Rating of Ataxia (SARA) over 1 year post DBS surgery
The Scale for the Assessment and Rating of Ataxia (SARA) is a validated scale for the assessment of ataxia. It was initially developed and tested for ataxia quantification due to spinocerebellar atrophy, but it has proven validity in the evaluation of ataxia caused by other etiologies . For this study, efficacy of DBS therapy will be measured as the proportion of patients with improved SARA score (a drop of at least one point) at 12 months.
Measured: The SARA scale will be assessed under both Stimulation ON and Stimulation OFF condition at- 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start2 Mar 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxia, GaitStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suneil Kalia, University Health Network, Toronto
- Investigators
- Suneil Kalia, MD PhD FAANS FRCSC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427563
- Sponsor's protocol ID
- 21-5959
- Acronym
- DBS-Ataxia
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar Deep Brain Stimulation for the Treatment of Refractory Ataxia and Gait Disorders: Pilot Trial
- ClinicalTrials.gov ID
- NCT07427563
- Acronym / sponsor ID
- DBS-Ataxia / 21-5959
- Conditions
- Ataxia, Gait
- Keywords
- deep brain stimulation (DBS), cerebellar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 23 Feb 2026 (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.
Abnormal gait is often associated with immobility and falls, which in turn lead to loss of functional independence and death. While gait disorders may arise from many different etiologies, dysfunction of the cerebellum (a part of the brain with the function of coordination of movement) leading to gait disorders results in distinct features. Gait ataxia is a specific type of neurological gait disorder and is defined as the presence of abnormal, uncoordinated movements associated with gait. To date, there are limited treatments for ataxia and/or gait disorders. Deep brain stimulation (DBS) is a neurosurgical tool that has been widely used for over twenty years, mainly to treat Parkinson's disease, dystonia, and essential tremor. In this study, we aim to implant DBS in patients with ataxia and/or gait disorder in the cerebellum area, and electrically stimulate them in a titratable and ultimately reversible manner. This study is divided into 3 phases: pre-operative, operative and post-operative phase. The purpose of this pilot study is to evaluate the safety, feasibility, and to validate the DBS of cerebellar cortical and deep nuclei in patients with treatment refractory ataxia. Twelve(12 ) patients will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurosurgery | Active comparator | Device: Deep Brain StimulationStandard of Care Neurosurgery for new indication |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or Male patients between age 20-70
- Diagnosis of primary ataxia (inclusive of congenital and hereditary subtypes without other neurological compromise)
- Head CT scan and cerebral MRI without any structural contraindications for safe DBS
- Patient able to give written consent
- Able to comply with all testing, follow-ups and study appointments and protocols
Key exclusion criteria (5 listed)
- Active neurologic disease including but not limited to epilepsy and certain brain tumors
- Secondary ataxia (such as due to stroke, medication, autoimmune disease, ischemia, tumor, or other lesion)
- Any contraindication to MRI scanning
- Likely to relocate or move during the study's one-year duration
- Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
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 StimulationStandard of care Neurosugical implantation of Deep Brain Stimulation under general anesthesia | Device | Neurosurgery |
Primary outcome
Incidence of DBS surgical complications defined by the CTCAE (2017)
Time frame: Surgical complication will assessed and recorded at 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP
The overall incidence of surgical complications will be documented and used as a safety parameter. Published complication rates for DBS surgery are between 4% to 30%, with an overall mean of 16% . Therefore, to be considered a safe treatment, incidence should not be higher than 30%. Surgical complication will be defined according to the CTCAE, documenting the cases of grade 2 to 5 (CTCAE, 2017).
1 secondary outcome
Improvement in Scale for the Assessment and Rating of Ataxia (SARA) over 1 year post DBS surgery
Time frame: The SARA scale will be assessed under both Stimulation ON and Stimulation OFF condition at- 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Suneil Kalia, MD PhD FAANS FRCSC principal investigator
University Health Network, Toronto
1 site 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 Ataxia, Gait, run by University Health Network, Toronto 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 5 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Altagracia Cantos (+1-416-603-5866, Altagracia.Cantos@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DBS surgical complications defined by the CTCAE (2017) (time frame: Surgical complication will assessed and recorded at 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP). 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 23 Feb 2026.