Recruiting

Deep Brain Stimulation

Sponsor:

University Health Network, Toronto

Code:

NCT07427563

Conditions

Ataxia, Gait

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation

Study Details

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.

Conditions

Ataxia, Gait

Study ID

NCT07427563

Start date

Mar 2, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Neurosurgery

Standard of Care Neurosurgery for new indication

Interventions

Deep Brain Stimulation

Standard of care Neurosugical implantation of Deep Brain Stimulation under general anesthesia

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 ]

Central Contacts and Locations

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 23, 2026

Last verified

Jan, 2026

Keywords

  • deep brain stimulation (DBS)
  • cerebellar

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-02-23.