Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain

Обзор

This study aims to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the upper limbs in people with hemiplegia following a stroke.

Подробное описание

The purpose of this study is to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. Participants will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, Participants will undergo a structured physical rehabilitation program and electrical stimulation. Researchers will quantify the motor potentials in the arm and hand muscles generated by EES of the cervical spinal cord, tune optimal stimulation parameters to induced arm and hand movement, and assess participant motor function of the upper limb with standard clinical tests and simple motor tasks.

Вмешательства

• Устройство Epidural electrical stimulation (EES)
  Subjects will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, subjects will undergo a structured physical rehabilitation program and electrical stimulation.

Первичные конечные точки

• Change in motor functioning and sensation as measured by the Fugl-Meyer Assessment (FMA) [Срок оценки: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation]
• Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT) [Срок оценки: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation]

Вторичные конечные точки (2)

• Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF) [Срок оценки: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation]
• Change in spasticity as measured by the Modified Ashworth Scale (MAS) [Срок оценки: Time Frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation]

Критерии участия

Критерии включения

• Between 20 and 70 years of age
• First-ever clinical manifest stroke
• Right or left hemiparesis
• Scores higher than 7 and lower than 45 on the Fugl-Meyer scale.
• Expected will undergo spinal cord stimulation surgery.
• Able to comply with procedures and follow up.
• Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities.

Критерии исключения

• Pregnancy or breast feeding.
• Have Major depressive disorder.
• Had a mental illness within one year or been treated in the past.
• Have significant cognitive impairment (MMSE<24) or serious disease that could affect the ability to participate in study activities.
• Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
• Receiving anticoagulant, anti-spasticity or anti-epileptic medications prior to or throughout the duration of the study.
• Unable to read and/or comprehend the consent form.
• Have concerns about this trial and do not sign consent.
• Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities.

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

Тайвань · 1 центр

• Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City

Идентификаторы

NCT: NCT05981989 · IRB112-125-A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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