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Neuromodulation for Spinal Cord Injury
Study Summary
This trial is testing whether it is safe to implant a cervical spinal cord stimulator in people with cervical SCI who need a ventilator to breathe. The study will also look at how well the stimulator works. People who qualify for the study will need to come in for testing up to twice a week for 21 months.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
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- I can go to weekly tests for up to 21 months.I can understand, follow instructions, and express my concerns.I had lung surgery within the last year or have a lung condition like asthma or COPD.I do not have any broken bones, muscle issues, open wounds, or infections.My spinal cord injury between the C2 and C7 vertebrae is stable.I have a spinal cord injury in my neck area.I rely on a ventilator and have low breathing strength.It has been over a year since my spinal cord injury.I have complete motor paralysis according to the ASIA scale.I can go to weekly tests for up to 21 months.It has been over a year since my injury.I have severe breathing problems.I am between 18 and 75 years old.I am between 18 and 75 years old.My chest, arms, and legs are structurally normal, and my muscles work properly.I have paralysis of the phrenic nerve.You have a history of severe autonomic dysreflexia, a condition where the body's response to stimuli is exaggerated and can cause dangerous spikes in blood pressure.You have severe depression or are currently addicted to drugs.You have a medical device called a phrenic nerve or diaphragm pacer.
- Group 1: Epidural Stimulation for Respiratory Function
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 1 Days to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 2 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Days after you stop receiving the treatment.
Frequently Asked Questions
Are there opportunities to join this clinical trial at the present time?
"Affirmative. Data available on clinicaltrials.gov suggests that this research is still hunting for participants, with the trial first posted on September 27th 2021 and last updated November 23rd 2021. 15 individuals need to be recruited from 2 sites."
What is the desired sample size for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical endeavour is actively recruiting participants as of November 23rd 2021. It was originally posted on September 27th 2021 and requires 15 patients from two separate sites."
Is this research initiative open to individuals who are over four decades of age?
"The age range accepted for enrolment in this medical trial is 18 to 75 years. There are 138 trials tailored for participants under the legal age and 735 studies designed for seniors aged 65 or older."
Is there an opportunity for me to participate in this clinical experiment?
"This clinical trial is seeking to enrol 15 individuals who have sustained a spinal cord injury, aged between 18 and 75. For entry into the study, patients must also meet additional qualifications such as non-progressive SCI at C2-C7 level of severity; ventilator dependency with low maximal inspiratory and expiration pressure; male or female gender within specified age range; one year post-injury duration; Motor Complete ASIA Impairment Scale (A, B); ability to attend weekly testing sessions for up to 21 months; intact chest/lungs, upper and lower extremity anatomy plus neuromuscular connections between"
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Most responsive sites:
- Semel Institute of Neuroscience at UCLA: < 24 hours
Average response time
- < 1 Day
Typically responds via
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