Bilateral Occipital Nerve Field Stimulation for the Prophylactic Treatment of Difficult-to-treat Chronic Cluster Headache

Man and Science, SA1 site in 1 country10 target enrollmentOctober 19, 2023

ConditionsChronic Cluster Headache

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Cluster Headache
Sponsor: Man and Science, SA
Enrollment: 10
Locations: 1
Primary Endpoint: Safety Evaluation of the Device [Time Frame:12 weeks / 48 weeks]
Status: Suspended
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 19, 2023

End Date

March 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Man and Science, SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ICHD-3 criteria for chronic cluster headache
•Documented history of CCH since at least 2 years
•Minimum mean attack frequency of 4 attacks per week
•Age range: 18-70 years
•Difficult-to-treat CCH with documented previous complete failure, insufficient efficacy, intolerance, or contra-indications to most preventive CH treatments among which are oral steroids or suboccipital infiltrations, verapamil, lithium carbonate and topiramate.
•No preventive CH treatment or stable preventive CH medication for ≥ 2 weeks before enrolment. Subject agrees not to change existing treatment during the whole duration of the trial.
•Subject written informed consent provided before enrolment
•Subject willing and capable of subjective evaluation and to fill in an electronic CH diary, to understand questionnaires, and to read, understand and sign the written informed consent form.
•Subject willing and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria

•Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.
•History of epilepsy, current treatment of epilepsy
•Documented history of cerebrovascular accident (CVA)
•Subjects suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Recreational use of cannabis is allowed.
•Subjects at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS
•Having another active implanted device such as a cardiac pacemaker, a spinal cord, peripheral nerve, sphenopalatine ganglion, or deep brain hypothalamic stimulator, and/or a drug delivery pump, etc.
•Cranial botulinum toxin injections in the past 3 months before enrolment. Administration of the following treatments in the last month before enrolment: monoclonal antibodies blocking calcitonin gene-related peptide transmission, suboccipital infiltrations with steroids and/or local anaesthetics, oral steroids, radiofrequency procedure or infiltrations of the sphenopalatine ganglion, opioids WHO
•Medication overuse headache (ICHD 3 8.2)
•Inability to fill out an electronic diary.
•Previous surgery or trauma involving the cervical spine or the occipital bone

Outcomes

Primary Outcomes

Safety Evaluation of the Device [Time Frame:12 weeks / 48 weeks]

Time Frame: 12-weeks post implantation and through study completion at 48 weeks

The primary endpoint is safety and is assessed through the incidence of procedure related and/or device-related adverse events during the 12-weeks post implantation and the rate of all adverse events during the entire 48-week study period.