Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury

Официальное название

Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury: Short and Long-Term Effects

Обзор

The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury. The main questions this study attempts to solve: 1. What are the immediate effects of spinal cord transcutaneous stimulation on BP? 2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?

Подробное описание

We want to find out if this stimulation can help both right away (during a session) and over time (after several sessions). Specifically, this study will look at whether spinal stimulation can treat orthostatic hypotension, which is a drop in blood pressure that happens when the patient moves from lying down to sitting or standing up. To take part, one must have had a spinal cord injury for more than one year.

Вмешательства

• Устройство Tilt test with stimulation (real-time effects): Intervention 1
  While lying supine, participants will be strapped to a Hi-Low tilt-table bed. The bed will gradually be tilted to a 70 degrees tilt, during which time continuous hemodynamic measures will be recorded. This position will be maintained for 30 minutes. During tilt, transcutaneous stimulation will be applied, using the configuration that was chosen based on the mapping sessions.
• Устройство 20 sessions of stimulation (Intervention 2)
  Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs

Первичные конечные точки

• Systolic blood pressure [Срок оценки: 1 month]
• Systolic blood pressure [Срок оценки: Through study completion, an average of 5 months]

Вторичные конечные точки (6)

• duration in tilt test [Срок оценки: Through study completion, an average of 5 months]
• Orthostatic symptoms questionnaire [Срок оценки: Through study completion, an average of 5 months]
• 24-hour ABPM OH events - taken at home [Срок оценки: Through study completion, an average of 5 months]
• Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores [Срок оценки: Through study completion, an average of 5 months]
• Spinal cord injury - quality of life scores [Срок оценки: Through study completion, an average of 5 months]
• Canadian Occupational Performance Measure scores [Срок оценки: Through study completion, an average of 5 months]

Критерии участия

Критерии включения

• Individuals with a SCI ≥ 1 year after injury
• Injury level ≥ T6 (thoracic level)
• AIS grade A-C
• Cardiovascular dysfunction characterized by one or more of the following:

• Persistent hypotension (SBP < 90mmHg)
• Orthostatic hypotension (OH, a drop of 20/10 mmHg in SBP/DBP within 5 minutes of standing/upright positioning).

Additionally, experiencing orthostatic symptoms in daily life and/or requiring medication to manage OH.

Критерии исключения

• Current illness (e.g., infection, a pressure injury that might interfere with the intervention)
• Ventilator-dependent
• History of implanted brain/spine/nerve stimulators
• Cardiac pacemaker/defibrillator or intra-cardiac lines
• Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction
• History of seizures
• pregnancy
• Insufficient mental capacity to understand and independently provide consent
• Deemed unsuitable by the study physician

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

США · 1 центр

• Kessler Foundation — West Orange

Идентификаторы

NCT: NCT07674511 · R-1323-26 · 1R03HD120505-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗