Deep Brain Stimulation for Spinocerebellar Ataxias

Not yet recruiting at 2 trial locations
ND
GB
Overseen ByGordon Baltuch, MD, PhD
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 tests a treatment called deep brain stimulation (DBS) to determine its safety and feasibility for people with certain types of spinocerebellar ataxia (SCA), a condition affecting balance and coordination. The main goal is to identify any side effects or issues from the treatment. Researchers also aim to assess whether DBS can alleviate symptoms and improve movement. This trial may suit adults diagnosed with moderate SCA type 1 or 3 who continue to experience symptoms despite regular treatment. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

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

The trial protocol does not specify if you need to stop taking your current medications, but you must have been on a stable treatment plan for at least 3 months before joining. You cannot participate if you are unable to stop blood-thinning medications for study procedures.

What prior data suggests that this deep brain stimulation system is safe for patients with Spinocerebellar Ataxia?

Research has shown that deep brain stimulation (DBS) is generally safe for patients with movement disorders, including some types of ataxia. In one study, patients did not experience major problems from the treatment. Another study examined a patient with a different type of ataxia and found a significant reduction in tremor severity, suggesting the treatment can be effective without causing significant harm.

However, some reports have mentioned complications, such as stimulation-induced ataxia, in a small number of cases, ranging from 5% to 40%. This indicates that while the treatment is mostly safe, there is a chance of experiencing some movement-related side effects. Despite these potential issues, researchers continue to study DBS because of its possible benefits for ataxia patients.

Overall, DBS for spinocerebellar ataxias appears safe, but like any medical treatment, it carries risks. Participants should discuss these risks with their healthcare providers before joining a trial.12345

Why are researchers excited about this trial?

Unlike the standard of care for spinocerebellar ataxias, which often involves medication to manage symptoms, Deep Brain Stimulation (DBS) offers a unique approach by directly targeting brain activity. DBS involves surgically implanting electrodes into specific brain areas to regulate abnormal signals, which could potentially improve motor control and coordination. Researchers are excited about DBS because it provides a more direct and possibly more effective way to address the neurological basis of the condition, rather than just alleviating symptoms. This could lead to significant improvements in quality of life for patients who currently have limited treatment options.

What evidence suggests that deep brain stimulation is effective for Spinocerebellar Ataxia?

Research has shown that deep brain stimulation (DBS) can improve symptoms in people with movement disorders, including certain types of ataxia. In this trial, participants will undergo DBS intervention, which involves surgical implantation of the DBS leads and a pulse generator. Previous studies demonstrated significant improvements in people with spinocerebellar ataxia, with benefits appearing as soon as six months after treatment. Specifically, in cases of SCA12, DBS reduced tremor severity by 76%. Additionally, combining DBS with exercise improved muscle function and mobility in ataxia models. These findings suggest that DBS could be a promising option for managing symptoms of spinocerebellar ataxia.46789

Who Is on the Research Team?

GB

Gordon Baltuch, MD

Principal Investigator

CUIMC

SK

Sheng-Han Kuo, MD

Principal Investigator

CUIMC

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Spinocerebellar Ataxia type 1 or type 3. Participants should be adults who meet specific medical criteria and do not have conditions that would make surgery unsafe.

Inclusion Criteria

Subject is available for all follow-up visits during the length of the study
Subject is able and willing to give informed consent and attend all study visits
Subject has a minimum 6th grade reading level, as determined by the Rapid Estimate of Adult Literacy in Medicine (REALM) scale
See 4 more

Exclusion Criteria

I have been diagnosed with epilepsy.
I cannot stop my blood thinner or anti-platelet medication for the study.
Subject has a major active psychiatric illness that may interfere with the study, such as psychiatric disorders or severe personality disorders
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Participants undergo surgical implantation of the DBS leads and pulse generator

1-2 weeks

Treatment

Participants receive deep brain stimulation and are monitored for safety and effectiveness

11 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Deep Brain Stimulation (DBS) System

Trial Overview

The study is testing the safety and practicality of using deep brain stimulation (DBS) in a part of the brain called the cerebellar nuclei to help manage symptoms in SCA1 and SCA3 patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DBS InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gordon H. Baltuch

Lead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Deep brain stimulation of the dentate nucleus improves ...

DBS improved medication refractory tremor in the SCA2 and the ataxia NOS patients. The outcome for the FXTAS patient was poor. DBS improved ...

Posterior Subthalamic Area Deep Brain Stimulation Combined ...

A case study of a 55-year-old man with SCA12 demonstrated significant improvements in tremor severity, with a 76% reduction on the Tremor Rating Scale following ...

Combination of deep brain stimulation and exercise has ...

DBS plus exercise improved the outcomes Neurostimulation with DBS improved muscle function and the general mobility of Car8 mice, but the ...

Cerebellar deep brain stimulation for movement disorders

We review the recent data of cerebellar DBS performed by different groups and summarize the indications, surgical targets, programming details ...

Can we treat spinocerebellar and other ataxias with deep ...

dentate nucleus deep brain stimulation delivered meaningful improvement to folks living w/ spinocerebellar ataxia at 6 months of follow … led ...

(PDF) Feasibility and Safety of Combined Cerebello-spinal ...

Results : Adherence was 97.3%, with no serious adverse events. Significant improvements were observed in SARA (P < 0.001), BBS (P < 0.001), and ...

Cerebellar Deep Brain Stimulation for Movement Disorders ...

The purpose of this study is to test the safety of placing Deep Brain Stimulators (DBS) known to be ineffective. Primary outcome measure ...

NCT02552628 | WILSTIM - DBS (WILson STIMulation

To evaluate the safety of STN/GPi DBS in the specific context of Wilson's disease. Detailed Description. 4 periods of stimulation on and off, sequence ...

Ataxia and tolerance after thalamic deep brain stimulation ...

Complications of stimulation-induced ataxia and tolerance have been reported in limited series, ranging from 5 to 40%. Objective: We analyzed a large single- ...