Cerebellar Deep Brain Stimulation for the Treatment of Ataxia
ConditionAtaxia, Gait
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorUniversity Health Network, Toronto
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Active neurologic disease including but not limited to epilepsy and certain brain tumors
Secondary ataxia (such as due to stroke, medication, autoimmune disease, ischemia, tumor, or other lesion)
Any contraindication to MRI scanning
Likely to relocate or move during the study's one-year duration
Trial design
Design model
Single group
Treatments tested in this trial
Deep Brain Stimulation
DeviceStandard of care Neurosugical implantation of Deep Brain Stimulation under general anesthesia
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: NeurosurgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of DBS surgical complications defined by the CTCAE (2017)
The overall incidence of surgical complications will be documented and used as a safety parameter. Published complication rates for DBS surgery are between 4% to 30%, with an overall mean of 16% . Therefore, to be considered a safe treatment, incidence should not be higher than 30%. Surgical complication will be defined according to the CTCAE, documenting the cases of grade 2 to 5 (CTCAE, 2017).
Time frame
Surgical complication will assessed and recorded at 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OPSecondary outcomes
1
Improvement in Scale for the Assessment and Rating of Ataxia (SARA) over 1 year post DBS surgery
The Scale for the Assessment and Rating of Ataxia (SARA) is a validated scale for the assessment of ataxia. It was initially developed and tested for ataxia quantification due to spinocerebellar atrophy, but it has proven validity in the evaluation of ataxia caused by other etiologies . For this study, efficacy of DBS therapy will be measured as the proportion of patients with improved SARA score (a drop of at least one point) at 12 months.
Time frame
The SARA scale will be assessed under both Stimulation ON and Stimulation OFF condition at- 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OPSponsors and contacts
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Source ClinicalTrials.gov