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NCT Number: NCT07427563

Cerebellar Deep Brain Stimulation for the Treatment of Ataxia

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.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location status: Recruiting

Location contact

Altagracia Cantos

CONTACT

[email protected]

416-603-5866

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Deep brain stimulation

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Altagracia Cantos

CONTACT

[email protected]

+1-416-603-5866

Tasnuva Hoque

CONTACT

[email protected]

416-603-5800 ext. 3421

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Cerebellar Deep Brain Stimulation for the Treatment of Refractory Ataxia and Gait Disorders: Pilot Trial

Acronym: DBS-Ataxia

Important dates

Study start
2023
Primary completion
2030
Study completion
2035
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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