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โ† Trials
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Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes

RecruitingNAAges 21 Years - anyAllUniversity of California, San Francisco
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is safe and may help patients recover their movement. The main questions it aims to answer are: * is starting electrical stimulation 3 days post SCI safe? * can starting electrical stimulation 3 days post SCI help patients recover movement? This study will be done in two phases. Both phases will be done during the patient's stay in the hospital/intensive care unit (ICU). In the first phase, participants' will undergo several tests before and after a single treatment. Assessments will be repeated before the patient will go home at around 7 days post injury. * assessment of the ability to move arms/legs and feel touch or pin prick * blood and cerebral spinal fluid draws * assessment of their spinal cord function using electrical stimulation * receive a s

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: A subject will be eligible for enrollment in the study of the following criteria apply: 1. Written informed consent is obtained. 2. Acute traumatic cervicothoracic SCI that meets all of the following criteria: 1. Acute SCI presenting to the hospital within 12 hours of injury 2. Traumatic non-penetrating SCI 3. American Impairment Scale (AIS) Grade A, B, or C 4. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological level of injury between C4 and T10 3. Aged \>/=18 years 4. Admission to Intensive Care Unite (ICU) with lumbar drain in place per standard of care Exclusion Criteria: A subject will not be eligible for this study if ANY of the following criteria apply: 1. Subjects classified as AIS D or E 2. Penetrating SCIs or complete transection of the spinal cord 3. Pregnancy 4. Incarceration or police custody 5. Class 2 or Class 3 obesity 6. Any concomitant injury that, in the judgment of the Investigator, interferes with the procedures and examinations required by the study protocol, including but not limited to: 1. multiple spinal cord lesions 2. fractures requiring lower extremity casts or splints 3. skin breakdown or burns over the lumbar spine 4. profound hemodynamic instability 5. traumatic brain injury (defined by Glasgow Coma Scale (GCS) \<14 at enrollment or inability to participate in exam)
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What it tests

  • transcutaneous spinal cord stimulation
  • sham transcutaneous spinal cord stimulation
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Where

1 site
Zuckerberg San Francisco General Hospital
San Francisco, 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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