Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313515
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-03
Brief Title:
Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Transcutaneous Spinal Cord Stimulation Combined With Arm Crank Exercise for Cardiovascular Recovery in Cervical and Upper Thoracic SCI
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spinal cord injury SCI can make it hard for the body to self-regulate some of its automatic functions like blood pressure breathing and heart rate This can also make it hard for those living with SCI to exercise or complete their usual daily activities The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation tSCS for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury SCI at or above the thoracic sixth spinal segment T6
The main questions the study aims to answer are
Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI T6
Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI T6
Evaluate the dosage-response of 8 weeks vs 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI T6
Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise
Participants will
Receive either transcutaneous spinal cord stimulation or sham spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks
Come in for approximately 60 visits over a 6-month period This includes 2 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise
During assessment visits the researchers will perform a variety of exams including a neurologic cardiovascular pulmonary physical and autonomic exam and will ask questions about quality of life and functioning
Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI
The main questions the study aims to answer are
Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI T6
Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI T6
Evaluate the dosage-response of 8 weeks vs 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI T6
Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise
Participants will
Receive either transcutaneous spinal cord stimulation or sham spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks
Come in for approximately 60 visits over a 6-month period This includes 2 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise
During assessment visits the researchers will perform a variety of exams including a neurologic cardiovascular pulmonary physical and autonomic exam and will ask questions about quality of life and functioning
Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None