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Transcutaneous Electrical Nerve Stimulation for Spinal Cord Injury (SCI Trial)
SCI Trial Summary
This trial is testing a new way to help people with spinal cord injuries who often have low blood pressure.
SCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSCI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SCI Trial Design
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Who is running the clinical trial?
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- I have a history of heart or blood vessel diseases.My injury occurred over a year ago.I cannot walk by myself.I am over 18 years old.I cannot walk by myself.My spinal cord injury is at or above the T6 level.I have had a blood clot or severe muscle tightness in the past year.I am currently dealing with an acute illness or infection.I have a history of diabetes, whether it's under control or not.I have a neurological condition that is not a spinal cord injury.You are not using a ventilator.Your blood pressure is too low. For males, the systolic (top number) is less than 110 or the diastolic (bottom number) is less than 70. For females, the systolic is less than 100 or the diastolic is less than 70.My spinal injury is classified as severe to moderate.My spinal cord injury is at or above the T6 level.You are not using a ventilator.
- Group 1: With Stimulation
- Group 2: Without Stimulation
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the primary aims of this research endeavor?
"This study aims to ascertain the Amplitude of TSCS over a two year period. Secondary measures include Velocity of Arterial Stiffness assessed via carotid and femoral artery Pulse Wave Velocity, Norepinephrine Concentration, and Systolic Blood Pressure in both unstimulated orthostatic tilt scenarios as well as under optimal stimulation."
Does this investigation only involve participants aged 60 and below?
"Participation in this study is limited to individuals aged 21-70 years. For persons younger than 18 and older than 65, there are 138 respective trials and 732 respectively."
How many individuals have been recruited to participate in this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that this medical research, initially posted on April 1st 2022, is in search of participants at the moment. 2 centres are recruiting for 10 patients in total."
Are new participants welcomed to join this research endeavor?
"According to clinicaltrials.gov, this study is currently recruiting participants having been initially posted on April 1st 2022 and most recently edited on the 18th of same month."
To whom is enrollment in this trial available?
"The medical trial is recruiting 10 individuals, aged between 21 and 70, who have suffered a traumatic wound. The participants must further meet the following criteria: being within the specified age range; spinal cord injuries at or above T6; non-ambulatory status; American Spinal Injury Association (ASIA) A, B or C scale classification of injury severity; able to provide informed consent for participation in this study; no ventilator hypotension (for males - systolic blood pressure below 110 mmHg and/or diastolic blood pressure lower than 70mmHg; for females - systolic BP under 100 mm"
Who else is applying?
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What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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