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โ† Trials
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Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

RecruitingNAAges 18 Years - 70 YearsAllVA Office of Research and Development
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In plain words

What the trial is, and whether it could suit you

In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Inclusion criteria for SCI: * Male and female Veterans between 18-70 years * Chronic SCI (1 year of injury) * Cervical injury at C8 or above - damage between cervical spinal segments will be confirmed using MRI \[preliminary data (Benavides et al., 2020) and analysis of MRIs in \~100 participants with cervical SCI confirm that the investigators can meet our recruitment goals. Note that most SCI in humans damage several spinal cord segments * Verification of damage to cervical spinal segments will ensure that TESS electrodes will target the injured spinal cord (Benavides et al., 2020) * Intact or impaired, but not absent, innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores as tested before in our studies (Bunday and Perez, 2012; Bunday et al., 2018; Benavides et al., 2020; Jo and Perez, 2020) * Able to produce a visible power grip with one hand * Can score a minimum of two (2) in the cylindrical grasp the "Prehension Ability" GRASSP * This criterion was selected to ensure that hand impairment will not interfere with the ability to perform training and the proposed tests Inclusion criteria for controls: * Males and females (18-70 years) * Right-handed * Able to complete grasping Exclusion Criteria: Exclusion criteria for SCI and control subjects: * Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease * Any debilitating disease prior to the SCI that caused exercise intolerance * Premorbid, ongoing major depression or psychosis, altered cognitive status * History of head injury or concussion, skull fractures (or any skull deficit), unexplained headaches in the last 6 months, or stroke * Pacemaker * 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 (chlorpromazine, clozapine) or tricyclic antidepressants * Pregnant females * Ongoing cord compression, or a syrinx in the spinal cord, or one who suffers from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk
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What it tests

  • TESS
  • Training
  • Motor Task
  • sham-TESS
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Where

2 sites
Shirley Ryan AbilityLab
Chicago, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, 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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