Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250491
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-23
Brief Title:
Deep rTMS H-coil for Neuropathic Pain or Fibromyalgia
Sponsor:
Nadine ATTAL
Organization:
Hospital Ambroise Paré Paris
Study Overview
Official Title:
Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia a Bicenter Randomized Sham Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
H-FINEP
Brief Summary:
This study will investigate the efficacy and safety of deep rTMS on neuropathic pain or fibromyalgia It will be randomized and sham controlled and will last 3 months Patients will be randomized to receive acctive rTMS or sham rTMS and will receive repeated rTMS sessions 5 daily sessions then one session per week then every 2 to 3 weeks for up to 10 weeks
Detailed Description:
This double blind sham controlled parallel group bicenter study will assess the efficacy and safety of repeated sessions of deep rTMS using H coil in patients with neuropathic pain or fibromyalgia Primary outcome will be of pain relief at week 13
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?:
False
Is an FDA AA801 Violation?:
None