Purpose of this Study
This study will last about two to a little over two years from the day you sign up until your last checkup. If the doctors decide you are a good fit after the first tests, you will have surgery to place the ARCIM System inside your body. After the surgery, you will have many checkups over the next two years so the study team can see how well the treatment is working for you.
During these visits, the team will adjust the device to make sure it works well for your daily life. You will also answer questions and take part in health checkups during clinic visits. Some visits will be done by email or phone. Altogether, you will spend about fifteen days in person at the clinic during the whole study. The study team will be there to help and guide you at every step.
Who Can Participate?
Eligibility
To join this study, a person must have had a spinal cord injury for more than one year and must be between 18 and 75 years old. Their injury must be between the C2 and T6 levels of the spine. They must have long-lasting low blood pressure and must not have had low blood pressure before their injury. They also need to have a certain score on a test called the ASIA scale, which shows how the injury affects the body.
Some people cannot join the study. This includes people who recently had a heart attack, a serious heart rhythm problem, or a stroke. People with kidney or liver disease cannot join. Someone who uses a ventilator or already has a device in their body, like a pump or pacemaker, cannot join. Pregnant or breastfeeding people cannot take part, and someone who cannot safely have a spinal MRI also cannot join.
Anyone who wants more information can email the study team at brittney.nickerson@duke.edu.
Age Range
18-75
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
After a spinal cord injury, a person’s body may have trouble keeping blood pressure at a safe level. Sometimes the blood pressure becomes too low or too high. This study wants to find out if a new medical device called the ARCIM System can safely and effectively help control these changes. The ARCIM System is being tested to see if it can help people who have had a spinal cord injury for more than one year and who have ongoing problems with blood pressure.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
ARC(IM) System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
Study Website
Principal Investigator
Shivanand
Lad
Protocol Number
PRO00117578
Enrollment Status
Pending Open to Enrollment