Cerebellar Deep Brain Stimulation for the Treatment of Ataxia (DBS-Ataxia)

February 20, 2026 updated by: Suneil Kalia, University Health Network, Toronto

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neurosurgery
Standard of Care Neurosurgery for new indication
Device: Deep Brain Stimulation
Standard of care Neurosugical implantation of Deep Brain Stimulation under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Surgical complication will assessed and recorded at 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Suneil Kalia, MD PhD FAANS FRCSC, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-5959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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