Neuromodulation After Spinal Cord Injury to Improve Limb Function

Обзор

The University at Buffalo (UB) Department of Rehabilitation Sciences is looking for adult volunteers with and without spinal cord injuries for a study on hand movement. The goal of the study is to learn about how the brain, nerves, and muscles of the body are connected and perform everyday tasks. This may help us to develop ways to improve the hand functions of people with spinal cord injuries.

Подробное описание

The main goal of rehabilitation strategies in humans with spinal cord injury (SCI) is to strengthen transmission in spared neural networks to restore functional movements. Recent evidence showed that neuromodulation approaches may increase the transmission in corticospinal pathway in humans with SCI and improve functional outcomes. Therefore, the investigators aim to investigate how the noninvasive brain stimulation protocols affects neuroplasticity of corticospinal pathway. Specifically, the investigators will use the repetitive transcranial magnetic stimulation (rTMS) to explore its effect. The investigators will investigate the effect of short-term and long-term rTMS application in individuals with SCI.

Вмешательства

• Другое rTMS
  Intermittent theta burst stimulation (iTBS) will be utilized since they have been reported to have a cortical neuromodulatory effect. The iTBS protocol will be applied over primary motor cortex to investigate its effect on corticospinal excitability and functional outcome. Theta burst stimulation (TBS) consists of bursts of pulses containing 3 pulses at 50 Hz (3 pulses per second) repeated at 200 ms intervals (5 Hz). During iTBS, a 2 second train of TBS is repeated every 10 seconds (600 pulses i
• Другое Sham rTMS
  Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
• Поведенческое Motor training
  The motor training will be focused on participant's hand motor function such as grasping function.

Первичные конечные точки

• Motor evoked potentials (MEP) [Срок оценки: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.]

Вторичные конечные точки (2)

• Maximum voluntary contraction (MVC) [Срок оценки: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.]
• Power Grip Forces [Срок оценки: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.]

Критерии участия

Критерии включения

• Healthy adults between the ages of 18-75 years old who are right-handed
• Adults between the ages of 18-75 years old who have had a spinal cord injury (SCI)

Критерии исключения

For both healthy individuals and those with SCI:

• Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
• Any debilitating disease prior to the SCI that caused exercise intolerance
• Ongoing major depression or altered cognitive status
• Metal plate in skull
• History of seizures
• Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs
• Pregnant females

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Kimball Tower at The State University of New York at Buffalo — Buffalo

Идентификаторы

NCT: NCT06815601 · 00007259

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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