Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage

Официальное название

Pilot Study: Dorsal Root Ganglion Stimulation After Spinal Cord Injury-Related Lower Motor Neuron Damage

Обзор

The purpose of this study is to study sensorimotor circuit activity generated in response to temporarily implanted dorsal root ganglion stimulation by recording from muscles of the lower extremities as well as functional outcomes achieved over a 10-day rehabilitation program in an individual with lower motor neuron injury.

Вмешательства

• Устройство Abbot Dorsal Root Ganglion Neurostimulator
  After temporary implantation of leads into the dorsal root ganglia of lower spine, the patient will undergo 2-3 hour sessions over 10 days. Each session will consist of rehabilitation exercises will receiving electrical spinal stimulation.

Первичные конечные точки

• Change America Spinal Injury Association (ASIA) Impairment Scale categorization [Срок оценки: Baseline, 14 days]

Вторичные конечные точки (3)

• Change in Neurogenic Bladder Symptom (NBSS) score [Срок оценки: Baseline, 14 days]
• Change in Neurogenic Bowel Dysfunction Survey (NBD) score [Срок оценки: Baseline, 14 days]
• Change in sexual function survey score [Срок оценки: Baseline, 14 days]

Критерии участия

Критерии включения

• Traumatic and non-traumatic spinal cord injury (SCI)
• ASIA Impairment Scale (AIS) A-D
• SCI below the tenth thoracic vertebral level
• Greater than 1 year post-SCI
• Intact spinal reflexes at or below injury level in 1 or more muscles

Критерии исключения

• Currently a prison inmate, or awaiting trial, related to criminal activity
• Pregnancy at the time of screening for trial enrollment
• Active, untreated urinary tract infection
• Unhealed decubitus ulcer
• Unhealed skeletal fracture
• Spinal abnormality that may impede percutaneous implantation of spinal electrodes
• Untreated clinical diagnosis of psychiatric disorder
• Joint contractures that impede typical range of motion
• Non-MRI-compatible implanted medical devices
• Other implanted stimulation devices (e.g., deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
• Active participation in an interventional clinical trial which, based on the research team's assessment, may compromise protocol compliance, safety, and/or validity of data collected during this study
• History of clinically diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
• History of frequent and/or severe autonomic dysreflexia
• History of seizure disorder
• Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study

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

Фундаментальное исследование

Центры проведения

США · 1 центр

• Mayo Clinic — Rochester

Идентификаторы

NCT: NCT07619300 · 26-003033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗