Neuromodulation to Improve Grasping Function After SCI

Официальное название

Neuromodulation to Improve Grasping Function After Spinal Cord Injury

Обзор

The goal of this study is to restore the activities of late descending signals with a noninvasive stimulation approach in combination with hand motor training to improve hand function in persons with cervical SCI. The main question it aims to answer is if the inputs to late descending signals above the level of injury and the output of residual late descending signals below the level of injury could be increased. Specifically, in the first part of the study, 30 participants will complete 2 randomized sessions to compare the effect of intermittent theta burst stimulation combined with paired corticospinal motoneuronal stimulation. In the second part of the study, 24 participants will complete either combined stimulation protocol or sham stimulation protocol with exercise training.

Подробное описание

The investigators will use paired corticospinal-motoneuronal stimulation (PCMS) in combination with intermittent theta burst stimulation (iTBS). During PCMS, the investigators will use paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation to improve corticospinal transmission and functional recovery in humans with cervical incomplete SCI. In addition, the investigators will investigate how priming iTBS affects neuroplasticity of late corticospinal descending volleys. The investigators will apply iTBS on primary motor cortex prior to paired stimulation with PCMS to facilitate late corticospinal volleys and potentiate the effect of PCMS. In Aim 2, the investigators propose to combine our neuromodulation in Aim 1 with long-term motor training focused on hand grasping to strengthen spared connections and promote functional improvement in humans with cervical incomplete SCI.

Вмешательства

• Другое iTBS
  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 iTBS
  Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
• Другое PCMS
  During PCMS, paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation will be used to improve corticospinal transmission.
• Другое Sham PCMS
  During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity.
• Поведенческое Exercise
  The motor training will be focused on participant's hand motor function such as grasping function.

Первичные конечные точки

• Motor evoked potential (MEP) [Срок оценки: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.]

Вторичные конечные точки (3)

• Maximum voluntary contraction (MVC) [Срок оценки: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.]
• Grip force [Срок оценки: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.]
• Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT) [Срок оценки: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.]

Критерии участия

Критерии включения

For individuals with SCI:

• Ages 18-75 years
• Chronic SCI (≥1 year of injury)
• Cervical injury at C8 or above
• Individuals who have MEP responses in at least one FDI muscle

Критерии исключения

• Uncontrolled medical problems including pulmonary or cardiovascular disease
• Premorbid, ongoing major depression or psychosis, altered cognitive status
• History of head injury or stroke
• 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
• Individuals who suffer from a spinal cord disease such as spinal stenosis, spinal bifida or herniated cervical

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The State University of New York at Buffalo — Buffalo

Идентификаторы

NCT: NCT07433959 · STUDY00009877

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗