Cerebellar Deep Brain Stimulation for the Treatment of Ataxia

NCT07427563 | Recruiting

• 1 other identifier: 21-5959
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

deep brain stimulation (DBS); cerebellar

Outcome Measures

Primary Outcomes (1)

• 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).

  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 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

Study Arms (1)

Neurosurgery

ACTIVE COMPARATOR

Standard of Care Neurosurgery for new indication

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

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

Neurosurgery

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Gait Ataxia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Ataxia; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Gait Disorders, Neurologic; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Suneil Kalia, MD PhD FAANS FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Altagracia Cantos

CONTACT

+1-416-603-5866; Altagracia.Cantos@uhn.ca

Tasnuva Hoque

CONTACT

416-603-5800; tasnuva.hoque@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 23, 2026
• Study Start: March 2, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: February 23, 2026

Record last verified: 2026-01

Locations

CA (1)