Ataxia, Gait
Conditions
Keywords
deep brain stimulation (DBS), cerebellar
Brief 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.
Interventions
DEVICEDeep Brain Stimulation
Standard of care Neurosugical implantation of Deep Brain Stimulation under general anesthesia
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Female or Male patients between age 20-70 2. Diagnosis of primary ataxia (inclusive of congenital and hereditary subtypes without other neurological compromise) 3. Head CT scan and cerebral MRI without any structural contraindications for safe DBS 4. Patient able to give written consent 5. Able to comply with all testing, follow-ups and study appointments and protocols
Exclusion criteria
1. Active neurologic disease including but not limited to epilepsy and certain brain tumors 2. Secondary ataxia (such as due to stroke, medication, autoimmune disease, ischemia, tumor, or other lesion) 3. Any contraindication to MRI scanning 4. Likely to relocate or move during the study's one-year duration 5. Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of DBS surgical complications defined by the CTCAE (2017) | Surgical complication will assessed and recorded at 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Scale for the Assessment and Rating of Ataxia (SARA) over 1 year post DBS surgery | 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 OP | 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. |
Countries
Canada
Contacts
CONTACTAltagracia Cantos
CONTACTTasnuva Hoque
PRINCIPAL_INVESTIGATORSuneil Kalia, MD PhD FAANS FRCSC
University Health Network, Toronto
Outcome results
None listed