Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT06124534
Status:
SUSPENDED
Last Update Posted:
2024-06-26
First Post:
2023-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH
Sponsor:
Man and Science, SA
Organization:
Study Overview
Official Title:
Bilateral Occipital Nerve Field Stimulation for the Prophylactic Treatment of Difficult-to-treat Chronic Cluster Headache
Status:
SUSPENDED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
device upgrade/requires competent authority approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BONS
Brief Summary:
The purpose of this study is to assess the initial safety, tolerability, and effectiveness of the novel BliStim occipital nerve field stimulation therapy for the prevention of chronic cluster headaches. This is a prospective, first in human study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: