Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)

Обзор

The purpose of this research is to examine the effects that functional electrical stimulation (FES) therapy has on the way the arms, brain and spinal cord work. The study team wants to understand what recovery looks like in persons with a spinal cord injury (SCI) or peripheral nerve injury (PNI) using the MyndMove (MyndTec Inc., Ontario, Canada) therapy system. This type of therapy uses stimulation to help people with SCI and other neurological conditions to perform common tasks, work out, or strengthen muscles.

Вмешательства

• Устройство MyndMove Short Term Therapy
  FES therapy will be provided in one visit (one hour duration) delivered within a 2 week period, in person. FES therapy uses surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements the single use electrodes will be placed in various combinations on the surface of the different upper arm muscles. Participants will perform hand and finger dexterity tests as well as arm functional m
• Другое Conventional Short Term Therapy
  Therapy will be provided in one visit (one hour duration) delivered within a 2 week period, in person. Conventional therapy will consist of performance hand and finger dexterity tests as well as arm functional mobility tasks
• Устройство MyndMove Long Term Therapy
  FES upper arm therapy will be provided in one-hour in-person sessions for a maximum of 40 sessions delivered no less than 3 times per week and up to 5 times per week during a period of up to 12 weeks. Over the course of 40 sessions, participants will progress through various movement sequences aimed at regaining natural, unassisted voluntary movements in the affected arms while receiving FES.

Первичные конечные точки

• Nine Hole Peg Test [Срок оценки: baseline and up to 2 weeks]
• Surface EMG [Срок оценки: baseline and up to 2 weeks]
• Graded-Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Prehension Performance (GR-PP) [Срок оценки: baseline, 12 weeks]
• Manual Muscle Test (MMT) with FES [Срок оценки: baseline, 12 weeks]

Критерии участия

Критерии включения

1\. Neurological Injury:

• Traumatic spinal cord injury (SCI): neurological level at or above T1 spinal cord level; AIS A, B, C or D impairment grade

• Group 1 (Acute SCI): Deemed medically stable by medical practitioner, less than 6 months post-injury.
• Group 2 (Chronic SCI): More than 6 months post-injury.

or

• Peripheral nerve injury (PNI), with or without SCI, who are pre- or post- upper extremity (UE) nerve transfer surgery

• Group 3 (Acute Pre- or Post-UE nerve transfer surgery): Deemed medically stable and safe/appropriate to participate in MyndMove UE FES therapy intervention by referring neurosurgeon within 6 months pre- or post-UE nerve transfer surgery.
• Group 4 (Chronic Post-UE nerve transfer surgery): Deemed medically stable and safe/appropriate to participate in MyndMove UE FES therapy intervention by referring neurosurgeon 6 months or more post-UE nerve transfer surgery.

3\. Has detectable residual connection in upper-limb muscles in at least one of the neurologically affected sides confirmed by a visible contraction when functional electrical stimulation (FES) is applied in at least one upper extremity muscle at baseline.

4\. Has detectable motor function in at least 1 upper extremity muscle on 1 neurologically affected side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) at the baseline assessment. 5. (Aim 2 only) Able to commit to intervention and assessment sessions over a maximum duration of 4 months.

Критерии исключения

• Traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
• Severe spasticity that could prevent the study protocol as determined by the investigator.
• Major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
• Has contraindications for transcutaneous stimulation using FES such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease
• Poorly managed autonomic dysreflexia that could be triggered by FES.
• Unhealed upper extremity fracture, contracture, or pressure sore.
• Implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation (VNS))
• Cardiac pacemaker or intracardiac lines.
• Individuals who require therapy or other care that could interfere with participation in the study.
• Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
• Individuals with substance disorders, including alcoholism and drug abuse.
• Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
• In the opinion of the investigators, the study is not safe or appropriate for the participant.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Miami - Miami Project to Cure Paralysis — Miami

Идентификаторы

NCT: NCT06672458 · 20240966

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗