Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT02435004
Status:
UNKNOWN
Last Update Posted:
2021-03-26
First Post:
2015-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy:
Sponsor:
Ospedale Regionale di Lugano
Organization:
Study Overview
Official Title:
Clinical Study Protocol Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
NSI-TD-002
Brief Summary:
A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in patients with small fiber neuropathy (SFN).
Detailed Description:
This study is a prospective, single-arm, mono-centre pilot study enrolling a maximum of 31 patients with SFN. All enrolled patients will receive a trial neurostimulation (TNS) lasting from 3 to 30 days and only patients with a positive result in terms of pain intensity reduction will be eligible for the implanted neurostimulation (INS) phase. The target number of patients eligible for INS is 10 and this population will be assessed for impact of DRGS on the neuropathic pain caused by SFN. The expected duration of patients participation will be 14 months. The rationale for this open label approach is that this is a novel technique for which pilot data with regard to applicability and efficacy have yet to be established. Data gathered in the study will provide preliminary data required to assess the feasibility of this intervention, to be used for possible future studies with a more rigorous methodological approach (i.e. controlled trial, randomized controlled trial).
Study Oversight
Has Oversight DMC:
False
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?: