Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT05398003
Status:
RECRUITING
Last Update Posted:
2024-11-18
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
Status:
RECRUITING
Status Verified Date:
2024-11
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:
S2M
Brief Summary:
Number of centres planned : 1 (CHU Nantes)
Design : Randomized, Prospective
Planning of the study :
* Total duration: 34 months
* Recruitment period: 24 months.
* Follow-up time per patients : 7-10 months
Expected number of cases : 12
Treatment, procedure, combination of procedures under consideration :
During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode.
There will be a random draw on the order of the stimulation program:
* the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias
* burst stimulation (or "burst")
* high frequency" stimulation (1000 Hz) "High frequency: HF".
* combined tonic + burst stimulation
* combined tonic + high frequency stimulation
Design : Randomized, Prospective
Planning of the study :
* Total duration: 34 months
* Recruitment period: 24 months.
* Follow-up time per patients : 7-10 months
Expected number of cases : 12
Treatment, procedure, combination of procedures under consideration :
During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode.
There will be a random draw on the order of the stimulation program:
* the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias
* burst stimulation (or "burst")
* high frequency" stimulation (1000 Hz) "High frequency: HF".
* combined tonic + burst stimulation
* combined tonic + high frequency stimulation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: