Menu
Recruiting NCT07427563

Cerebellar Deep Brain Stimulation for the Treatment of Ataxia

No phase Interventional Ataxia, Gait

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation.
Who it may be relevant to
Registry conditions: Ataxia, Gait. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Toronto Western Hospital — Toronto

Identifiers

NCT: NCT07427563 · 21-5959

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗