Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641271
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function The main questions it aims to answer are
Is stimulating the vagus nerve safe and feasible after demyelinating episodes
Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis
Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control
Participants will
Come in for study visits over a six month period Study visits are three times weekly for the first month then single follow up visits at two three and six months
During study visits participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task specifically the grooved peg test
At various timepoints in the study motor and disability tests will be administered to see if there are any changes in motor control for that participants These tests include the timed 25 foot walk test expanded disability scale the upper extremity portion of the Fugl-Meyer Assessment and the Multiple Sclerosis Impact Scale - 29
Is stimulating the vagus nerve safe and feasible after demyelinating episodes
Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis
Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control
Participants will
Come in for study visits over a six month period Study visits are three times weekly for the first month then single follow up visits at two three and six months
During study visits participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task specifically the grooved peg test
At various timepoints in the study motor and disability tests will be administered to see if there are any changes in motor control for that participants These tests include the timed 25 foot walk test expanded disability scale the upper extremity portion of the Fugl-Meyer Assessment and the Multiple Sclerosis Impact Scale - 29
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