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Tests treatment safety and results for Acute Spinal Cord Injury (SCI)
Official title Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes
ClinicalTrials.gov ID: NCT07090473
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- A subject will be eligible for enrollment in the study of the following criteria apply:
- Written informed consent is obtained.
- Acute traumatic cervicothoracic SCI that meets all of the following criteria:
- Acute SCI presenting to the hospital within 12 hours of injury
- Traumatic non-penetrating SCI
You likely can't join if
- A subject will not be eligible for this study if ANY of the following criteria apply:
- people classified as AIS D or E
- Penetrating SCIs or complete transection of the spinal cord
- Pregnancy
- Incarceration or police custody
- Class 2 or Class 3 obesity
See the full eligibility criteria
- A subject will be eligible for enrollment in the study of the following criteria apply:
- Written informed consent is obtained.
- Acute traumatic cervicothoracic SCI that meets all of the following criteria:
- Acute SCI presenting to the hospital within 12 hours of injury
- Traumatic non-penetrating SCI
- American Impairment Scale (AIS) Grade A, B, or C
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological level of injury between C4 and T10
- Aged \>/=18 years
- Admission to Intensive Care Unite (ICU) with lumbar drain in place per standard of care
- A subject will not be eligible for this study if ANY of the following criteria apply:
- people classified as AIS D or E
- Penetrating SCIs or complete transection of the spinal cord
- Pregnancy
- Incarceration or police custody
- Class 2 or Class 3 obesity
- 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:
- multiple spinal cord lesions
- fractures requiring lower extremity casts or splints
- skin breakdown or burns over the lumbar spine
- profound hemodynamic instability
- traumatic brain injury (defined by Glasgow Coma Scale (GCS) \<14 at enrollment or inability to participate in exam)
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.