跳至主要内容
临床试验/NCT06440538
NCT06440538
进行中(未招募)
早期 1 期

Improving Upper Limb Rehabilitation by Rebuilding Inter-limb Transfer of Motor Gains in Cervical SCI

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 17 人2024年2月15日

概览

阶段
早期 1 期
干预措施
未指定
疾病 / 适应症
Cervical Spinal Cord Injury
发起方
The Cleveland Clinic
入组人数
17
试验地点
2
主要终点
Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS)
状态
进行中(未招募)
最后更新
上个月

概览

简要总结

The purpose of this study in people living with cervical Spinal Cord Injury (SCI) is to examine the effects of paired neurostimulation (i.e., PCMS) combined with contralateral motor training on inter-limb transfer of ballistic motor and hand dexterity skills.

详细描述

Cervical spinal cord injury (SCI) is the most common and severe type of SCI that can lead to paralysis of the trunk and all four limbs, also known as tetraplegia. People with tetraplegia place a high priority on regaining upper limb motor function to be independent in daily life. Despite intensive therapies, upper limb motor gains are slow to emerge, especially in chronic cases. A critical barrier to effective and efficient upper limb rehabilitation in cervical SCI lies in the motor deficits of inter-limb transfer. Inter-limb transfer refers to a natural innate process within the human neuromotor system that motor skills acquired in one limb can transfer to the opposite, untrained limb, and is believed to play a key role in maximizing and accelerating post-injury recovery. Inter-limb transfer however is deficient following cervical SCI due to a breakdown of inter-limb neural connections at the cortical and spinal levels. Prior studies in uninjured people reveal that one can upregulate inter-limb neural mechanisms and hence augment inter-limb transfer effects by giving neurostimulation to augment corticomotoneuronal pathways to the untrained arm just before motor training in the contralateral arm. This study aims to rebuild inter-limb transfer of motor gains in chronic cervical SCI using a novel non-invasive neurostimulation method called paired corticospinal-motor neuronal stimulation (PCMS). We will test the central hypothesis that PCMS given to an untrained hand immediately before the visuomotor ballistic motor training at the other hand will improve inter-limb transfer of ballistic motor and dexterity skills to the untrained hand, based on potentiation of inter-limb neural mechanisms.

注册库
clinicaltrials.gov
开始日期
2024年2月15日
结束日期
2026年7月30日
最后更新
上个月
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

Ela B. Plow

Associate Proffesor

The Cleveland Clinic

入排标准

入选标准

  • Neurological Level of Injury C4, C5, C6, C7, C8
  • American Spinal Injury Association Impairment Scale (AIS) C-D
  • greater than or equal to 1 year time post injury
  • residual motor sparing of bilateral FDI muscles, defined as medical research council (MRC) grade 2 to 5

排除标准

  • contraindications to transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) including pacemaker, metal in the skull, seizure history, pregnancy, etc.
  • history of alcohol and/or drug abuse
  • current usage of medications that can potentially lower the seizure threshold such as bupropion, amphetamines, etc.
  • history of other neurological conditions such as stroke, Parkinson's, and traumatic brain injury (TBI)
  • active pressure ulcers to avoid disruption of ongoing medical treatments
  • participation of on-going upper-limb therapies to minimize confounding effects
  • excessive tone/spasticity (Modified Ashworth Scale \[MAS\] \>3) and severe contractures or soft tissue shortening at elbow/wrist/fingers

结局指标

主要结局

Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS)

时间窗: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

Transcranial magnetic stimulation will be used to test cortical output from both hemispheres and will be measured as motor evoked potentials(MEPS) of the First Dorsal Interosseous (FDI) muscle.

Change in ballistic acceleration

时间窗: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

Participants perform 10 trials of ballistic index finger abduction with a accelerometer attached to index finger to capture the peak acceleration during the movement.

Change in excitability of spinal physiology (F-wave)

时间窗: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

Peripheral Nerve stimulation will be performed to collect the spinal F-wave amplitude of the First Dorsal Interosseous (FDI) muscle.

次要结局

  • Change in finger velocity smoothness during NHPT(Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours)
  • Change in Nine Hole Peg Test (NHPT)(Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours)

研究点 (2)

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