12 Participants NeededMy employer runs this trial

Deep Brain Stimulation for Gait Ataxia

(DBS-Ataxia Trial)

AC
TH
Overseen ByTasnuva Hoque
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if deep brain stimulation (DBS), a technique often used for Parkinson's disease, can benefit individuals with gait ataxia, a condition causing unsteady walking due to brain coordination issues. The study will assess the safety and practicality of using DBS on the cerebellum, the brain region controlling movement, for those whose ataxia has not improved with other treatments. This trial suits patients aged 20-70 with primary ataxia and no other neurological issues. Participants must attend all appointments and adhere to study protocols. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options for ataxia.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this deep brain stimulation is safe for treating gait ataxia?

Research has shown that deep brain stimulation (DBS) for cerebellar ataxia is generally safe and well-tolerated. Several studies have examined its safety when targeting the cerebellum, the part of the brain that helps control movement. One study found that DBS in the dentate nucleus (a specific area in the cerebellum) was safe and helped reduce tremors linked to cerebellar disorders. Another study observed that five patients with cerebellar ataxia experienced modest improvements after receiving DBS.

These studies have not reported any major safety concerns. DBS has been used for over twenty years, mainly for conditions like Parkinson's disease, which suggests it has a strong safety record. However, like any surgery, DBS carries risks, and participants should discuss these with their doctors.12345

Why are researchers excited about this trial?

Unlike standard treatments for gait ataxia, which often focus on physical therapy and medication to manage symptoms, cerebellar deep brain stimulation directly targets the brain's cerebellum to potentially improve motor function. This technique involves implanting electrodes in the brain to modulate neural activity, offering a new way to address the underlying neural dysfunction rather than just alleviating symptoms. Researchers are excited about this approach because it could lead to more significant and lasting improvements in balance and coordination for patients, potentially transforming their quality of life.

What evidence suggests that cerebellar deep brain stimulation is effective for gait ataxia?

Studies have shown that deep brain stimulation (DBS) targeting the cerebellum can help improve walking difficulties. Several small studies and case reports have found modest improvements in symptoms like balance and walking. In one study, five patients with cerebellar ataxia noticed better movement after receiving DBS. Another study found similar benefits for patients with spinocerebellar ataxia, a genetic disorder affecting movement. These findings suggest that DBS may help manage walking difficulties by stimulating specific brain areas involved in movement coordination. Participants in this trial will receive cerebellar DBS to evaluate its effectiveness for gait ataxia.13456

Who Is on the Research Team?

SK

Suneil Kalia, MD PhD FAANS FRCSC

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults aged 20-70 with primary ataxia (including congenital or hereditary types) who have trouble walking and haven't responded to other treatments. Participants must be able to consent, attend all visits, and have no major health issues that make surgery risky.

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.
See 2 more

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
See 2 more

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

Trial Overview

The study tests deep brain stimulation (DBS), where electrodes are surgically placed in the cerebellum to help improve unsteady gait caused by ataxia. The procedure is adjustable and reversible. Only 12 patients will participate in this pilot safety and feasibility study.

How Is the Trial Designed?

1

Treatment groups

Active Control

Group I: NeurosurgeryActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

Deep Brain Stimulation for Cerebellar Ataxia - PMC - NIH

Several case reports and small studies on DN stimulation have reported modest but measurable improvements in symptoms such as gait, stance and ...

Cerebellar deep brain stimulation for movement disorders

In a recent study, five patients with cerebellar ataxia, either hereditary or secondary, who received cerebellar DBS displayed modest improvements in ataxia ...

Dentate Nucleus Deep Brain Stimulation for Spinocerebellar ...

This study assessed the treatment outcomes of DBS targeting the cerebellar dentate nucleus (DN) in SCA patients over a 6-month follow-up.

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.

Real‐time field‐programmable gate array‐based closed‐loop ...

Our real‐time FPGA‐based DCN‐DBS system could be a potential clinical strategy for alleviating cerebellar ataxia and other movement disorders.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34480330/

Safety and Outcomes of Dentate Nucleus Deep Brain ...

DN DBS is a safe and well tolerated procedure that is effective in alleviating cerebellar tremor.