Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05661903
Status:
RECRUITING
Last Update Posted:
2023-06-15
First Post:
2022-12-14
Brief Title:
From Nerve to Brain Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
From Nerve to Brain Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Status:
RECRUITING
Status Verified Date:
2023-06
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:
This is a multicenter prospective study of patients who currently have stably implanted spinal cord simulators Patients will be randomly assigned to turn on or off their spinal cord stimulators for two week intervals up to six weeks after enrollment and on the final day of study participation for one hour intervals in a multi-crossover design
Detailed Description:
The fundamental hypothesis for this study is that spinal cord stimulators modulate the excitability of primary afferent neurons to reduce pain and that these changes can be detected by measurement of axonal excitability For the primary outcome the study investigators will leverage the sensitivity and reproducibility of threshold tracking nerve conduction studies to detect changes in the excitability of thickly myelinated nerve fibers The study investigators will use microneurography to record directly from primary nociceptive afferents Finally the study investigators will perform plasma inflammatory cytokine profiles to measure changes due to spinal cord stimulators By correlating changes in outcome measurements with subject pain levels during therapeutic versus minimal spinal cord stimulators settings this study will determine which effects may be mechanistically relevant and which are unrelated to reduction in pain Thus this study will use robust reproducible techniques to define the peripheral central and systemic effects of spinal cord stimulators
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1RM1NS128741-01 | NIH | None | httpsreporternihgovquickSearch1RM1NS128741-01 |