New Spinal Cord Injury
Research Study
Research Study
Researchers from Baylor Scott & White Institute for Rehabilitation and the Texas Biomedical Device Center at The University of Texas at Dallas are studying new treatment methods aimed at improving arm function after a spinal cord injury
New Spinal Cord Injury
Research Study
Research Study
Researchers from Baylor Scott & White Institute for Rehabilitation and the Texas Biomedical Device Center at The University of Texas at Dallas are studying new treatment methods aimed at improving arm function after a spinal cord injury
Visits Conducted in Dallas, TX
Compensation Provided
18 - 64 Years Old
spinal cord injury Occured More than 12 months ago
Fast Facts
Study Background
Texas Biomedical has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury.
Researchers at the University of Texas at Dallas are evaluating how vagus nerve stimulation coupled with rehabilitation is able to improve recovery of arm function in people living with a spinal cord injury.
All participants will have the opportunity to receive treatment.
Researchers at the University of Texas at Dallas are evaluating how vagus nerve stimulation coupled with rehabilitation is able to improve recovery of arm function in people living with a spinal cord injury.
All participants will have the opportunity to receive treatment.
The purpose of this study is to assess if implanted vagus nerve stimulation (VNS) coupled with rehabilitation is able to improve recovery of arm function in people living with a spinal cord injury.
You may qualify for this study if you meet the following criteria.
Key Criteria:
Key Criteria:
- Must be a person living with cervical spinal cord injury for at least 12 months
- Must be between the ages of 18 and 64 years
- Must demonstrate some arm and hand movement
Therapy will take place over six weeks and long-term assessment of safety will be performed twice yearly for up to 2 years.
Pre-Therapy: During the first six weeks, participants will undergo consent, assessment, surgical implantation, and group assignment. Participants must wait a minimum of two weeks after surgery to start rehabilitation.
Phase 1: The Immediate Start VNS group will receive rehabilitation and active stimulation for 18 in-office sessions over the course of approximately 6 weeks. The Delayed Start VNS group will receive equivalent rehabilitation with placebo stimulation. Assignments for placebo or active stimulation in Phase 1 are random. An assessment will be performed approximately one week after the completion of the 18 sessions of rehabilitation.
Phase 2: Subjects who do not exit the study at the end of Phase 1 will participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately 6 weeks. All participants will receive active stimulation. Participants will be assessed approximately 1 week after the conclusion of the additional 18 sessions of therapy.
Long-term Follow Up: Safety will be assessed in all participants, regardless of whether they elect to exit after Phase 1 or continue into the Phase 2 open-label extension, twice per year for up to 2 years after the date of the implant. Participants will have the option to leave the device implanted, and participants may be offered the opportunity to participate in a follow-on study during this period. Aside from participation in a follow-on study, there is no plan to stimulate during this period. Safety assessments will only report on the presence of the implanted device and/or participant status during this period. Participants who experience a serious device-related adverse event will be removed from the identified risk but will continue to be monitored for 2 years or longer if the event has not been resolved.
Pre-Therapy: During the first six weeks, participants will undergo consent, assessment, surgical implantation, and group assignment. Participants must wait a minimum of two weeks after surgery to start rehabilitation.
Phase 1: The Immediate Start VNS group will receive rehabilitation and active stimulation for 18 in-office sessions over the course of approximately 6 weeks. The Delayed Start VNS group will receive equivalent rehabilitation with placebo stimulation. Assignments for placebo or active stimulation in Phase 1 are random. An assessment will be performed approximately one week after the completion of the 18 sessions of rehabilitation.
Phase 2: Subjects who do not exit the study at the end of Phase 1 will participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately 6 weeks. All participants will receive active stimulation. Participants will be assessed approximately 1 week after the conclusion of the additional 18 sessions of therapy.
Long-term Follow Up: Safety will be assessed in all participants, regardless of whether they elect to exit after Phase 1 or continue into the Phase 2 open-label extension, twice per year for up to 2 years after the date of the implant. Participants will have the option to leave the device implanted, and participants may be offered the opportunity to participate in a follow-on study during this period. Aside from participation in a follow-on study, there is no plan to stimulate during this period. Safety assessments will only report on the presence of the implanted device and/or participant status during this period. Participants who experience a serious device-related adverse event will be removed from the identified risk but will continue to be monitored for 2 years or longer if the event has not been resolved.
You will be compensated for your participation in this study
There is no cost for you to participate in our research program.