Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.

Обзор

The aim of this clinical trial is to determine whether deep brain stimulation (DBS) interventions improve rehabilitation and functional recovery in patients with post-stroke spasticity who meet the other inclusion criteria listed below. Primary question(s) to be answered: Is DBS stimulation effective in treating post-stroke spasticity? What stimulation frequency is most effective in treating post-stroke spasticity? Study participants will: * Undergo surgery to implant a DBS electrode targeting the DRTt (dentate-rubro-thalamic tract ) in close proximity of the dentate nucleus of the cerebellum ipsilateral to the spastic side of the body. * Each patient will then receive an initial stimulation frequency of 130 Hz (arm 1) and will be assigned to a 4- to 6-week rehabilitation program. After this period, the participant will return for a follow-up visit for a clinical evaluation. * The frequency will then be changed to 70Hz (arm 2). Patients who have undergone this change will also undergo a rehabilitation period of 4 to 6 weeks. After this period, they will return to the Clinic for a follow-up evaluation. * The frequency will then be changed to 30Hz (arm 3). Patients who have undergone this change will also undergo a rehabilitation period of 4 to 6 weeks. Researchers will compare the results obtained from patients in each arm to determine the clinical effects of stimulation and whether they are dependent on the stimulation frequency.

Вмешательства

• Процедура Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus
  The intervention will involve implantation of a directional electrode with a target in the dentate nucleus of the cerebellum, ipsilateral to the limbs affected by spasticity. Electrode implantation will be performed using a stereotaxic frame, following prior planning of the electrode trajectory and tractography of the dento-ruborothalamic tract using a planning station. The procedure will be performed under general anesthesia. The IPG stimulator will be placed in the subclavicular region.

Первичные конечные точки

• Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract. [Срок оценки: 6 weeks]

Вторичные конечные точки (3)

• Decrease of Ashworth Scale score after the rehabilitation with dentate-rubro-thalamic tract [Срок оценки: 6 weeks]
• Improvement in motor function achieves in Motor Assessment Scale MAS with stimulation dentate-rubro-thalamic tract [Срок оценки: 6 weeks]
• Improvement in Modified Rankin Scale after the rehabilitation with stimulation of dentato-rubro-thalamic tract [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• One time stroke that occurred 9-36 months ago
• Ischemic or hemorrhagic stroke
• Spastic paresis of at least one limb
• At least 3 months of poststroke rehabilitation in the past
• No improvement of spasticity/motor function for at least 3 months

Критерии исключения

• Seizures after the stroke
• Depression
• Severe sensory deficits
• Anosognosia
• Moderate to severe hemispatial neglect
• Others contraindications for the DBS procedure, e.g. coagulopathy, decompensated chronic disease, etc.
• Contraindication for MRI
• No poststroke rehabilitation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicola — Bydgoszcz

Идентификаторы

NCT: NCT07190092 · KB 314/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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