Cerebellar Deep Brain Stimulation for the Treatment of Ataxia

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Deep Brain Stimulation
  Standard of care Neurosugical implantation of Deep Brain Stimulation under general anesthesia

Первичные конечные точки

• Incidence of DBS surgical complications defined by the CTCAE (2017) [Срок оценки: Surgical complication will assessed and recorded at 2 week , 1Month, 2Month, 3Month, 4 Month, 5Month, 6Month, 8Month, 10Month and 12 Month post OP]

Вторичные конечные точки (1)

• Improvement in Scale for the Assessment and Rating of Ataxia (SARA) over 1 year post DBS surgery [Срок оценки: 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]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Toronto Western Hospital — Toronto

Идентификаторы

NCT: NCT07427563 · 21-5959

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗