Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546371
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-22
Brief Title:
Spinal Cord Stimulation for Intractable Mononeuropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Spinal Cord Stimulation for Intractable Mononeuropathy a Pilot Study
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:
SCIMONO
Brief Summary:
Rationale For patients with mononeuropathy literature has shown that spinal cord stimulation SCS is an effective therapy for patients who are therapy-resistant to more conventional treatments However there is a strong need for higher quality evidence to determine the place of this therapy in this target group Before conducting a large RCT we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done We will assess the effects of SCS in patients with mononeuropathy measured according to the IMMPACT guidelines and assess the stimulation paradigm preferences in these patients
Objective To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done Study design Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus MC Study population 12 patients suffering from intractable peripheral mononeuropathic pain Intervention if applicable Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months Main study parametersendpoints Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines
Objective To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done Study design Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus MC Study population 12 patients suffering from intractable peripheral mononeuropathic pain Intervention if applicable Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months Main study parametersendpoints Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines
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