NCT07427563 Cerebellar Deep Brain Stimulation for the Treatment of Ataxia
| NCT ID | NCT07427563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Ataxia, Gait |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-03-02 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2023-03-02 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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.
Contact & Investigator
Suneil Kalia, MD PhD FAANS FRCSC
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT07427563 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 70 Years, studying Ataxia, Gait. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07427563 currently recruiting?
Yes, NCT07427563 is actively recruiting participants. Contact the research team at Altagracia.Cantos@uhn.ca for enrollment information.
Where is the NCT07427563 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07427563 clinical trial?
NCT07427563 is sponsored by University Health Network, Toronto. The principal investigator is Suneil Kalia, MD PhD FAANS FRCSC at University Health Network, Toronto. The trial plans to enroll 12 participants.