Cerebellar deep brain stimulation to improve ataxia and walking
Cerebellar Deep Brain Stimulation for the Treatment of Refractory Ataxia and Gait Disorders: Pilot Trial
This study will try placing adjustable deep brain stimulation devices in the cerebellum to see if they improve walking and coordination in adults with primary ataxia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07427563 on ClinicalTrials.gov |
What this trial studies
The study implants deep brain stimulation (DBS) electrodes in the cerebellar region and delivers titratable electrical stimulation, with treatments that can be adjusted or reversed. Participants go through pre-operative screening, the operative implantation, and post-operative programming and follow-up. Eligible adults with primary ataxia will be monitored over time for changes in gait, coordination, and safety outcomes. The protocol excludes people with secondary ataxia, active neurologic disease, MRI contraindications, or medical conditions that make surgery high-risk.
Who should consider this trial
Good fit: Adults aged 20–70 with a diagnosis of primary (including hereditary or congenital) ataxia who can undergo MRI, give informed consent, and commit to follow-up appointments are eligible.
Not a fit: People with secondary causes of ataxia, active neurologic disease (for example epilepsy), major medical comorbidities that increase surgical risk, MRI contraindications, or who cannot remain in the area for the study duration are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could improve gait, reduce falls, and increase daily independence for people with primary ataxia.
How similar studies have performed: DBS is well established for Parkinson's disease and tremor, but cerebellar DBS for ataxia is largely experimental with only limited case series and early reports suggesting possible benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female or Male patients between age 20-70 2. Diagnosis of primary ataxia (inclusive of congenital and hereditary subtypes without other neurological compromise) 3. Head CT scan and cerebral MRI without any structural contraindications for safe DBS 4. Patient able to give written consent 5. Able to comply with all testing, follow-ups and study appointments and protocols Exclusion Criteria: 1. Active neurologic disease including but not limited to epilepsy and certain brain tumors 2. Secondary ataxia (such as due to stroke, medication, autoimmune disease, ischemia, tumor, or other lesion) 3. Any contraindication to MRI scanning 4. Likely to relocate or move during the study's one-year duration 5. Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
Where this trial is running
Toronto, Ontario
- Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Suneil Kalia, MD PhD FAANS FRCSC — University Health Network, Toronto
- Study coordinator: Altagracia Cantos
- Email: Altagracia.Cantos@uhn.ca
- Phone: +1-416-603-5866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.