Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552611
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Current disease-modifying therapies for multiple sclerosis MS aim to prevent the development of new lesions unfortunately no current FDA-approved therapies promote central nervous system CNS repair mechanisms Thus strategies to promote functional recovery from lesion-related deficits in adults with MS remain an unmet need
This is a pilot study designed to test the feasibility safety and preliminary efficacy of non-invasive transcutaneous applied by surface electrodes over the skin electrical spinal cord stimulation combined with occupational therapy for restoring upper extremity sensorimotor function in adults with multiple sclerosis
Participants with multiple sclerosis and impaired upper extremity function will complete two separate 6-week intervention sessions 6 weeks of occupational therapy combined with transcutaneous spinal cord stimulation and 6 weeks of occupational therapy alone The order of these interventions will be randomized and each intervention will be separated by a 6-week washout period
The investigators hypothesize that
1 transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants
2 transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone
3 transcutaneous spinal cord stimulation combined with therapy will lead to improvements in symptoms related to quality of life pain spasticity and bladder symptoms compared to occupational therapy alone
This is a pilot study designed to test the feasibility safety and preliminary efficacy of non-invasive transcutaneous applied by surface electrodes over the skin electrical spinal cord stimulation combined with occupational therapy for restoring upper extremity sensorimotor function in adults with multiple sclerosis
Participants with multiple sclerosis and impaired upper extremity function will complete two separate 6-week intervention sessions 6 weeks of occupational therapy combined with transcutaneous spinal cord stimulation and 6 weeks of occupational therapy alone The order of these interventions will be randomized and each intervention will be separated by a 6-week washout period
The investigators hypothesize that
1 transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants
2 transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone
3 transcutaneous spinal cord stimulation combined with therapy will lead to improvements in symptoms related to quality of life pain spasticity and bladder symptoms compared to occupational therapy alone
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