Long-term Follow-up for Epidural Stimulation in SCI

Официальное название

Multi Site Long-term Follow-up for Those With Experimental Epidural Stimulation After Severe Spinal Cord Injury

Обзор

The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury. The main aims are to: 1. provide support for those with epidural stimulators who choose to continue stimulating because they deemed them to improve their quality of life 2. provide additional sites for follow-up so that the financial burden can be minimized for the research participants to travel 3. collect long-term safety data; and 4. when feasible collect data to understand the sustainability of outcomes. Participants will: * receive stimulation programs and software for the activities and/or functions completed in the previous study and demonstrate to the research staff that I can conduct them without their help to use at home * continue using the stimulation programs at home as directed by the research staff * return to Kessler Foundation for a follow-up visit (approx. 2 hours) with assessments at 6 months, 1 year, and once a year after enrolled in the follow-up study last until either the device is turned off, removed or the device is commercially approved.

Подробное описание

SCI participants who previously had an epidural stimulation device and completed the initial study can continue using stimulation programs at home once they have proven to study staff that they can use the programs and device on their own. This follow-up study will give insight into potential benefits from long-term use of spinal stimulation.

In-person follow-up visits (approx. 2 hours long) will be requested at 6-months, 1 year, and once a year until the device is removed or approved for commercial use. If the participant can't come to Kessler for an in-person visit, a remote tele-health visit will be arranged. Visits include:

* medical history since the last visit will be collected * a physical exam * assessments completed during the study previously enrolled in including:

* Testing of muscle and limb responses to stimulation * Assessment of sitting, standing, and stepping function * Bladder and bowel function tests * Spasticity assessments * Blood pressure monitoring * Questionnaires * MRI * TMS * DXA * The study physician will contribute to decisions about which of these assessments are most appropriate to perform at a particular visit * The investigators will review stimulation logs * The investigator will review results of the assessments and discuss continuing in the follow up study.

Вмешательства

• Устройство Epidural Stimulation Programs
  Epidural stimulations will accompany stimulation programs that have been established during research visits in the prior study and have been recommended by the clinical research team for use in the home and community. Stimulation programs will be given for activities (such as standing or walking) and/or responses that were completed in the previous study. This will be continued until the device is removed or approved for commercial use.

Первичные конечные точки

• Motor Control Assessments with stimulation [Срок оценки: On average, 1 hour each visit completed 6 months, 1 year, and yearly]
• Bladder Function Assessment [Срок оценки: on average, 30 minutes each visit completed 6 months, 1 year, and yearly]
• Cardiovascular Assessment [Срок оценки: 24 hours prior to visit, completed 6 months, 1 year, and yearly]

Вторичные конечные точки (3)

• Questionnaires [Срок оценки: On average, 30 minutes each visit completed 6 months, 1 year, and yearly]
• Imaging Assessments [Срок оценки: On Average, 15 minutes each visit completed 6 months, 1 year, and yearly]
• Spasticity Monitoring [Срок оценки: Each visit completed 6 months, 1 year, and yearly]

Критерии участия

Критерии включения

• at least 18 years of age
• have a spinal cord injury that is not getting worse
• received a neurostimulator and electrode array as part of a previous study
• choose to continue epidural stimulation in the home and community
• have completed a previous IRB approved epidural stimulation study at a participating research site

Критерии исключения

• heart, lung, bladder, kidney or other untreated medical disorder unrelated to SCI
• choose not to use the epidural stimulation as recommended by the investigators
• withdrawn from the main epidural stimulation study or made the choice to remove the stimulator/return the controller to the site
• new surgeries, diagnoses, or other changes in status since completion of main epidural study that may affect the ability to complete assessments
• Unable to undergo an MRI
• Conditions that may make me ineligible for transcranial magnetic stimulation (a kind of brain stimulation through the skin)

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

Поддерживающая терапия

Центры проведения

США · 1 центр

• Kessler Foundation — West Orange

Идентификаторы

NCT: NCT07042815 · R-1273-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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