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โ† Trials
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Combining Spinal Cord Transcutaneous Stimulation and Activity-based Training in Inpatient Rehabilitation to Facilitate Upper Limb Function of Individuals with Acute to Subacute Cervical Spinal Cord Injury

RecruitingNAAges 18 Years - 75 YearsAllKessler Foundation
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical trial is to understand the safety and practicality of using spinal cord transcutaneous (through the skin) stimulation in an inpatient setting as well as how the combination of activity-based training (ABT) and spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hands, arms, and trunk in an inpatient rehabilitation program. The main questions it aims to answer are: * Is the combination of spinal cord transcutaneous stimulation and ABT is safe and practical when applied to individuals with acute to subacute cervical SCI during inpatient rehabilitation? * How the combined intervention can improve hand and arm function when applied to those individuals? The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention and compare to a sham control (sham stimulation combined with

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * must be at least 18 years of age. * must have had a spinal cord injury for less than or equal to 8 weeks. * must have a traumatic cervical SCI with lesions (AIS A or B, C5-C7). * must have some degree of motor dysfunction in the hand (bilateral UE motor score \<25). * must be medically stable enough to participate in activity-based recovery training. * must be able to tolerate spinal cord transcutaneous stimulation, as determined by study staff. * must have ability to understand and the willingness to sign an informed consent. Exclusion Criteria: * have a history of seizures, head trauma and/or cognitive deficit * have surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull * have a pressure sore or skin issues. * have severe spasticity. * in medically unstable condition. * have a history of illicit drug abuse. * have a history of medical disorders of my heart, lungs, bladder, kidneys or other parts of my body that are unrelated to my spinal cord injury. * unable or unwilling to wean from anti-spasticity medication (for an example: baclofen, Xeomin, and Lioresal). * unable to meet the attendance requirements. * currently enrolled in another interventional research study. * unable to follow instructions and maintain alertness during assessments and training.
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What it tests

  • Active Stimulation
  • Sham
  • Training only
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Where

1 site
Kessler Foundation
West Orange, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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