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Blood Flow Restricted Exercise + Transspinal Stimulation for Quadriplegia (SCIMS Main Trial)
SCIMS Main Trial Summary
This trial is testing whether a home-based exercise program supported by telehealth, combining Blood Flow Restricted Exercise and Transspinal Stimulation, will improve motor and functional abilities more than the same program with sham Transspinal Stimulation.
SCIMS Main Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSCIMS Main Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SCIMS Main Trial Design
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Who is running the clinical trial?
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- I do not have an implanted device, cancer, thrombosis, pacemaker, defibrillator, seizures, and I'm not on blood thinners.I do not have severe scoliosis or arm contractures that would stop me from participating in specific physical activities.My wrist muscles respond to electrical stimulation therapy.I am experiencing symptoms of a urinary tract infection.I have someone who can assist me during the study.Your blood pressure is higher than 140/80 mmHg while at rest.I am on blood thinners that I cannot stop for medical reasons.I have an ongoing deep vein clot.I do not have heart conditions that make it unsafe for me to join.I have episodes of sudden high blood pressure that medication cannot control due to my spinal cord injury.You have an incomplete spinal cord injury with certain levels of impairment as indicated by the American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D.I have severe muscle stiffness.Women are not pregnant and will take a pregnancy test before and during the study.I do not have severe neurological conditions like MS, CP, severe TBI, or stroke.You have a pacemaker or defibrillator implanted in your body.I have uncontrolled diabetes, hypertension, or cardiovascular disease.I have a broken bone in my arm or leg that hasn't healed.I have severe pressure sores.You have mental or thinking problems that make it hard for you to follow the treatment plan.My neurological condition is worsening due to a spinal cord injury.My spinal cord injury is above C8 and happened over a year ago.My wrist muscles respond to electrical stimulation on both sides.
- Group 1: BES+sham TS
- Group 2: BES+TS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this research endeavor accepting participants aged 55 and over?
"This experiment is open to all individuals who are 18 years of age or above and below the age of 70."
Is it possible for new participants to enroll in this research trial?
"The information posted on clinicaltrials.gov confirms that enrollment for this medical study is still open; the trial was initially uploaded to the website 15th June 2022 and was last updated 24th June 2022."
Are there any specific demographics that are favored to enroll in this study?
"This medical trial is seeking 44 participants between the ages of 18 and 70 who have suffered from quadriplegia. To be considered, individuals must also meet the following requirements: they should possess a companion that can help them throughout their study period; it has been more than one year since their spinal cord injury (SCI); neurologic level of C8 or higher; American Spinal Injury Association Impairment Scale scores B-D, signifying an incomplete SCI; visible muscle contraction response to NMES wrist extensors on both sides when exposed to neuromuscular electrical stimulation; clearance from a doctor confirming participant's ability"
What is the maximum cohort size for this clinical research?
"Affirmative. The clinical trial is actively recruiting according to the data hosted on clinicaltrials.gov, which was initially posted on June 15th 2022 and subsequently updated a week ago. This medical study seeks 44 participants at 3 distinct research sites."
What are the key goals of this investigation?
"This medical trial will assess Change in hand functional activities as its primary outcome, with Baseline to 20 weeks being the time frame of interest. Secondary evaluation criteria include Changes in heart rate variability (assessed via Tilt table test), Changes in capacity to perform functional activities (measured using SCI-FI SF) and finally Change in vital capacity which is determined through Forced vital capacity testing."
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