Deep Brain Stimulation for Spinocerebellar Ataxias
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.12345Why 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?
Gordon Baltuch, MD
Principal Investigator
CUIMC
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation
Participants undergo surgical implantation of the DBS leads and pulse generator
Treatment
Participants receive deep brain stimulation and are monitored for safety and effectiveness
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will undergo surgical implantation of the DBS leads, followed by a second surgery to implant a pulse generator (IPG) which generates electricity.
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
Citations
1.
researchgate.net
researchgate.net/publication/286404142_Deep_brain_stimulation_of_the_dentate_nucleus_improves_cerebellar_ataxia_after_cerebellar_strokeDeep 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 ...
3.
news-medical.net
news-medical.net/news/20210227/Combination-of-deep-brain-stimulation-and-exercise-has-potential-benefits-for-treating-ataxia.aspxCombination 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 ...
4.
researchgate.net
researchgate.net/publication/364606453_Cerebellar_deep_brain_stimulation_for_movement_disordersCerebellar 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 ...
9.
mayoclinic.elsevierpure.com
mayoclinic.elsevierpure.com/en/publications/ataxia-and-tolerance-after-thalamic-deep-brain-stimulation-for-es/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- ...
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