Deep Brain Stimulation for Gait Ataxia

(DBS-Ataxia Trial)

Overseen By Tasnuva Hoque

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Epilepsy, Brain tumors, Secondary ataxia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

Suneil Kalia, MD PhD FAANS FRCSC

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

Inclusion Criteria

I have primary ataxia without other neurological problems.

Head CT scan and cerebral MRI without any structural contraindications for safe DBS

I am able to understand and sign a consent form.

Exclusion Criteria

My ataxia is caused by another condition like stroke or medication.

Likely to relocate or move during the study's one-year duration

Any contraindication to MRI scanning

Timeline for a Trial Participant

Pre-operative

Participants undergo pre-operative assessments and preparations for DBS surgery

2-4 weeks

Operative

Participants undergo DBS surgery for implantation in the cerebellum area

1 day

1 visit (in-person)

Post-operative

Participants are monitored for surgical complications and initial DBS adjustments

12 months

Regular visits at 2 weeks, 1, 2, 3, 4, 5, 6, 8, 10, and 12 months post-operation

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cerebellar Deep Brain Stimulation

How Is the Trial Designed?

Group I: Neurosurgery Active Control 1 Intervention

Standard of Care Neurosurgery for new indication

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+