Deep Brain Stimulation Clinical Trials

Clinical trials related to Deep Brain Stimulation Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Toronto Western Hospital
RECRUITING
Toronto
Contact Information
Primary
Altagracia Cantos
Altagracia.Cantos@uhn.ca
+1-416-603-5866
Backup
Tasnuva Hoque
tasnuva.hoque@uhn.ca
416-603-5800
Time Frame
Start Date: 2023-03-02
Estimated Completion Date: 2035-12-31
Participants
Target number of participants: 12
Treatments
Active_comparator: Neurosurgery
Standard of Care Neurosurgery for new indication
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov