Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540859
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized single-blind two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation tSCS over the lower thoracic and upper lumbar spinal cord segments for cardiovascular function in adults 21-65 years old with cervical and upper thoracic spinal cord injury SCI T6 AIS A-D during inpatient rehabilitation and outpatient visits within three months after the onset We will recruit 26 individuals with SCI admitted to inpatient rehabilitation facilities IRFs or after discharged from IRFs We will also examine the effect of tSCS on lower urinary tract LUT and bowel functions as secondary outcomes
The main questions this study aims to answer are
1 Assess the safety of single and repeated tSCS sessions on cardiovascular function in the acute SCI We will test the safety of single tSCS at T10-L2 session at rest and during orthostatic challenge ie situ-up tests at the baseline and the effect of five tSCS sessions on cardiovascular function in individuals with SCI T6
2 Assess the effect of long-term tSCS on autonomic function in the subacute SCI phase We will investigate the efficacy of long-term total 18 sessions tSCS on cardiovascular and pelvic organ functions
3 Evaluate the sustained effect of tSCS on autonomic recovery six months after the onset of SCI We will assess the sustained effect of repeated tSCS sessions 18 sessions on cardiovascular and pelvic organ functions at 6-month post-SCI
Participants will
Receive either transcutaneous spinal cord stimulation or sham spinal cord stimulation while inpatient in the first 8 weeks Part A
Those willing and able to come after discharge or after the 8 weeks will be asked to come back and complete additional tSCS for a total of 18 weeks Part B with a follow-up period of 6 months All participants will receive tSCS during this outpatient follow-up portion of the study
During assessment visits the researchers will perform a variety of exams including a neurologic cardiovascular pulmonary bladder and bowel physical and autonomic exam and will ask questions about quality of life and functioning Participants will be asked to complete a test of how well their bowels are functioning colonic transit test and an abdominal X-Ray
Researchers will compare those who receive tSCS to those who receive sham stimulation to see if tSCS is an effective treatment for improving the bodys autonomic functioning following recent-onset SCI
The main questions this study aims to answer are
1 Assess the safety of single and repeated tSCS sessions on cardiovascular function in the acute SCI We will test the safety of single tSCS at T10-L2 session at rest and during orthostatic challenge ie situ-up tests at the baseline and the effect of five tSCS sessions on cardiovascular function in individuals with SCI T6
2 Assess the effect of long-term tSCS on autonomic function in the subacute SCI phase We will investigate the efficacy of long-term total 18 sessions tSCS on cardiovascular and pelvic organ functions
3 Evaluate the sustained effect of tSCS on autonomic recovery six months after the onset of SCI We will assess the sustained effect of repeated tSCS sessions 18 sessions on cardiovascular and pelvic organ functions at 6-month post-SCI
Participants will
Receive either transcutaneous spinal cord stimulation or sham spinal cord stimulation while inpatient in the first 8 weeks Part A
Those willing and able to come after discharge or after the 8 weeks will be asked to come back and complete additional tSCS for a total of 18 weeks Part B with a follow-up period of 6 months All participants will receive tSCS during this outpatient follow-up portion of the study
During assessment visits the researchers will perform a variety of exams including a neurologic cardiovascular pulmonary bladder and bowel physical and autonomic exam and will ask questions about quality of life and functioning Participants will be asked to complete a test of how well their bowels are functioning colonic transit test and an abdominal X-Ray
Researchers will compare those who receive tSCS to those who receive sham stimulation to see if tSCS is an effective treatment for improving the bodys autonomic functioning following recent-onset SCI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None