Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379711
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-02
Brief Title:
Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The aim of this study is to examine the mechanisms of transcutaneous spinal cord stimulation tSCS for improving cardiovascular and pulmonary function in individuals with chronic motor-complete spinal cord injury SCI by measuring vascular related endothelial biomarkers plasma catecholamines and respiratory parameters
Detailed Description:
DETAILED RESEARCH PROCEDURES
A INFORMED CONSENT
Prospective participants will be provided with the study informed consent form and will be given at least 24 hours to review the form ask questions and discuss with whomever they like
B VISIT 1 -Screening
Approximately 1 hour
Individuals who agree to participate in the study will be invited for a screening assessment to confirm study eligibility After the individual has provided informed consent they will be assigned a unique study identification number and the information listed below will be collected
Screening questionnaires and assessments
InclusionExclusion Criteria confirmation
Demographics
Medical history and history of injury
Concomitant medication use
Weight and height
Previous allergies and adverse events to medications
Pregnancy screening will be performed
Internationals Standards for Neurological Classification of Spinal Cord Injury ISNCSCI exam
C VISITS 2-5 -Baseline functional assessments questionnaires and cardiopulmonary assessments
Approximately 2 hours per visit
Enrolled participants will complete questionnaires after which a spirometry assessment for pulmonary function will be performed Participants will be provided with a 24-hour Ambulatory Blood Pressure Monitor 24- ABPM device to take home to record daily changes in cardiovascular parameters
Questionnaires Visit 2
Short-form 36 Health Survey SF-36
Autonomic Dysfunction following SCI ADFSCI questionnaire
Leisure Time Physical Activity Questionnaire after SCI LTPAQ-SCI
National Health Interview Survey - Chronic Conditions
American Thoracic Society ATS Adult Respiratory Disease Survey - Tobacco Use
Baseline cardiopulmonary and optional functional assessments with and without tSCS Visits 2-5
Spirometry testing Visit 2
24-hour Ambulatory Blood Pressure and electrocardiogram Monitoring 24-hr ABP and ECG Monitor Visit 2
Somatosensory evoked potentials Visit 3 optional
Transcranial Magnetic Stimulation Visit 4 optional
H-reflex Visit 5 optional
Compound Muscle Action Potentials Peripheral nerve stimulation Visit 5 optional
Muscle Ultrasound Visit 5 optional
Participants will also be provided with instructions to prepare for Visit 3 or 6 depending on whether they do the optional assessments during which blood samples will be collected Participants will be asked to
Arrive for testing in a fasted state fasted for 12 hours but they may continue to drink water
Not consume caffeine recreational drugs alcohol smoking or antihypotensive drug eg midodrine for 12 hours prior to their appointment
No strenuous exercise within 24 hours of the start of the study
D VISITS 3-5 or 6-8 depending on whether or not the optional functional assessments were completed earlier in the study Baseline cardiovascular assessments and blood draws
Approximately 3 hours
In this session participants will return the 24-hour ABP and ECG Monitor and undergo baseline cardiovascular assessments as well as the blood draws The participant has the option of only taking part in one or all cardiovascular assessments If the participant chooses to undergo more than one cardiovascular assessment they will be conducted on different visits
Cardiovascular Assessments
Cardiovascular stress test orthostatic stress test andor vibrostimulation or DARS
Blood Draws
Four 4 blood draws will be taken
1 At rest without tSCS
2 At rest with tSCS
3 During cardiovascular stress test without tSCS
4 During cardiovascular stress test with tSCS
E TREATMENT VISITS minimum 12 tSCS visits depending on whether or not the optional functional and cardiovascular assessments were done earlier in the study to completion of long-term intervention with tSCS intervention
Each session will last approximately 90 minutes set-up AND at least 45min of tSCS treatment
Long-term tSCS is scheduled to last for a minimum of two times per week for 6 weeks
Following the completion of the intervention participants will begin post-intervention questionnaires and cardiopulmonary assessments Week to week variation in the number of scheduled sessions may vary due to varying circumstances eg scheduling transportation participant health However the total number of sessions conducted will be the same as the participants original goal
F SECOND TO LAST VISIT Post-intervention questionnaires and cardiopulmonary assessment
Approximately 2 hours
In this session participants will complete post-intervention questionnaires and undergo post-intervention cardiopulmonary assessments
Questionnaires
Short-form 36 Health Survey SF-36
Autonomic Dysfunction following SCI ADFSCI questionnaire
Leisure Time Physical Activity Questionnaire after SCI LTPAQ-SCI
National Health Interview Survey - Chronic Conditions
American Thoracic Society ATS Adult Respiratory Disease Survey - Tobacco Use
Cardiopulmonary Assessments
Spirometry testing
24-hour ABP and ECG Monitor
G LAST VISIT Post-intervention cardiovascular assessments and blood draws
Approximately 3 hours
In this session participants will undergo post-intervention cardiovascular assessments as well as the blood draws
Cardiovascular Assessments
Carotid and cardiac ultrasound
Cardiovascular stress test orthostatic hypotension stress andor vibrostimulation or DARS
Blood Draws
Four 4 blood draws will be taken
1 At rest without tSCS
2 At rest with tSCS
3 During a cardiovascular stress without tSCS
4 During a cardiovascular stress with tSCS
A INFORMED CONSENT
Prospective participants will be provided with the study informed consent form and will be given at least 24 hours to review the form ask questions and discuss with whomever they like
B VISIT 1 -Screening
Approximately 1 hour
Individuals who agree to participate in the study will be invited for a screening assessment to confirm study eligibility After the individual has provided informed consent they will be assigned a unique study identification number and the information listed below will be collected
Screening questionnaires and assessments
InclusionExclusion Criteria confirmation
Demographics
Medical history and history of injury
Concomitant medication use
Weight and height
Previous allergies and adverse events to medications
Pregnancy screening will be performed
Internationals Standards for Neurological Classification of Spinal Cord Injury ISNCSCI exam
C VISITS 2-5 -Baseline functional assessments questionnaires and cardiopulmonary assessments
Approximately 2 hours per visit
Enrolled participants will complete questionnaires after which a spirometry assessment for pulmonary function will be performed Participants will be provided with a 24-hour Ambulatory Blood Pressure Monitor 24- ABPM device to take home to record daily changes in cardiovascular parameters
Questionnaires Visit 2
Short-form 36 Health Survey SF-36
Autonomic Dysfunction following SCI ADFSCI questionnaire
Leisure Time Physical Activity Questionnaire after SCI LTPAQ-SCI
National Health Interview Survey - Chronic Conditions
American Thoracic Society ATS Adult Respiratory Disease Survey - Tobacco Use
Baseline cardiopulmonary and optional functional assessments with and without tSCS Visits 2-5
Spirometry testing Visit 2
24-hour Ambulatory Blood Pressure and electrocardiogram Monitoring 24-hr ABP and ECG Monitor Visit 2
Somatosensory evoked potentials Visit 3 optional
Transcranial Magnetic Stimulation Visit 4 optional
H-reflex Visit 5 optional
Compound Muscle Action Potentials Peripheral nerve stimulation Visit 5 optional
Muscle Ultrasound Visit 5 optional
Participants will also be provided with instructions to prepare for Visit 3 or 6 depending on whether they do the optional assessments during which blood samples will be collected Participants will be asked to
Arrive for testing in a fasted state fasted for 12 hours but they may continue to drink water
Not consume caffeine recreational drugs alcohol smoking or antihypotensive drug eg midodrine for 12 hours prior to their appointment
No strenuous exercise within 24 hours of the start of the study
D VISITS 3-5 or 6-8 depending on whether or not the optional functional assessments were completed earlier in the study Baseline cardiovascular assessments and blood draws
Approximately 3 hours
In this session participants will return the 24-hour ABP and ECG Monitor and undergo baseline cardiovascular assessments as well as the blood draws The participant has the option of only taking part in one or all cardiovascular assessments If the participant chooses to undergo more than one cardiovascular assessment they will be conducted on different visits
Cardiovascular Assessments
Cardiovascular stress test orthostatic stress test andor vibrostimulation or DARS
Blood Draws
Four 4 blood draws will be taken
1 At rest without tSCS
2 At rest with tSCS
3 During cardiovascular stress test without tSCS
4 During cardiovascular stress test with tSCS
E TREATMENT VISITS minimum 12 tSCS visits depending on whether or not the optional functional and cardiovascular assessments were done earlier in the study to completion of long-term intervention with tSCS intervention
Each session will last approximately 90 minutes set-up AND at least 45min of tSCS treatment
Long-term tSCS is scheduled to last for a minimum of two times per week for 6 weeks
Following the completion of the intervention participants will begin post-intervention questionnaires and cardiopulmonary assessments Week to week variation in the number of scheduled sessions may vary due to varying circumstances eg scheduling transportation participant health However the total number of sessions conducted will be the same as the participants original goal
F SECOND TO LAST VISIT Post-intervention questionnaires and cardiopulmonary assessment
Approximately 2 hours
In this session participants will complete post-intervention questionnaires and undergo post-intervention cardiopulmonary assessments
Questionnaires
Short-form 36 Health Survey SF-36
Autonomic Dysfunction following SCI ADFSCI questionnaire
Leisure Time Physical Activity Questionnaire after SCI LTPAQ-SCI
National Health Interview Survey - Chronic Conditions
American Thoracic Society ATS Adult Respiratory Disease Survey - Tobacco Use
Cardiopulmonary Assessments
Spirometry testing
24-hour ABP and ECG Monitor
G LAST VISIT Post-intervention cardiovascular assessments and blood draws
Approximately 3 hours
In this session participants will undergo post-intervention cardiovascular assessments as well as the blood draws
Cardiovascular Assessments
Carotid and cardiac ultrasound
Cardiovascular stress test orthostatic hypotension stress andor vibrostimulation or DARS
Blood Draws
Four 4 blood draws will be taken
1 At rest without tSCS
2 At rest with tSCS
3 During a cardiovascular stress without tSCS
4 During a cardiovascular stress with tSCS
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?:
None
Is an FDA AA801 Violation?:
None