Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH (BONS)

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

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.

Study Overview

• Status: Suspended
• Conditions: Chronic Cluster Headache
• Intervention / Treatment: Device: Neurostimulation of the Occipital Nerve Field

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Sint-Niklaas, Belgium
    • VITAZ Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ICHD-3 criteria for chronic cluster headache
2. Documented history of CCH since at least 2 years
3. Minimum mean attack frequency of 4 attacks per week
4. Age range: 18-70 years
5. 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.
6. 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.
7. Subject written informed consent provided before enrolment
8. 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.
9. Subject willing and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

1. Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.
2. History of epilepsy, current treatment of epilepsy
3. Documented history of cerebrovascular accident (CVA)
4. 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.
5. Subjects at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS
6. 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.
7. 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 3.
8. Medication overuse headache (ICHD 3 8.2)
9. Inability to fill out an electronic diary.
10. Previous surgery or trauma involving the cervical spine or the occipital bone
11. Coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period.
12. Concurrent participation in another clinical study
13. Planned pregnancy, pregnancy, or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blistim System; Occipital Nerve Stimulation using the BliStim Occipital Nerve Stimulator	Device: Neurostimulation of the Occipital Nerve Field; BliStim Neurostimulation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation of the Device [Time Frame:12 weeks / 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.	12-weeks post implantation and through study completion at 48 weeks

Collaborators and Investigators

• Sponsor: Man and Science, SA
• Investigators: Principal Investigator: J-P Van Buyten, VITAZ Hospital, Sint Niklaas, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): November 21, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cluster Headaches
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: DOC-130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No