The purpose of this research study is to test the safety of a new investigational noninvasive spinal cord stimulation device called ExaStim and to see if it will help improve movement and sensation in the upper body, arms, and hands of individuals with spinal cord injury.
If you choose to participate, you will be asked to:
- Attend all scheduled visits (a total of 28 visits, lasting approximately 13 weeks), including a screening visit to ensure you meet all of the criteria for the study, 24 visits where you will receive the study treatment or a sham treatment, 2 visits to check on your hand functions in the middle and end of the treatment, and a follow-up visit 4 weeks after the last treatment visit to check on your well-being
- Answer any questions truthfully, including questions about your medications and medical history
- Be willing and able to follow the study directions and procedures
- Tell the study staff about any problems or side effects
- Ask questions as you think of them
- Tell the investigator or study staff if you change your mind about staying in the study
- Receive study compensation
The ASPIRE study is currently enrolling participants who are at least 22 years of age and have a traumatic, chronic spinal cord injury between C2 and T2, but who maintain limited function of the upper extremities. Participants must be willing to cooperate with the study requirements, including compliance with the treatment plan and completion of all office visits at Mount Sinai. Interested?
Visit the ASPIRE Study website and click “See if You May Qualify” or contact Arianny Ramirez for more information.
Chung-Ying Tsai, PhD is the principal investigator of this project.