Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH

NCT06124534 | Suspended DMC

• 1 other identifier: DOC-130
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cluster Headache

Keywords

Cluster Headaches

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Blistim System

EXPERIMENTAL

Occipital Nerve Stimulation using the BliStim Occipital Nerve Stimulator

Device: Neurostimulation of the Occipital Nerve Field

Interventions

Neurostimulation of the Occipital Nerve Field DEVICE

BliStim Neurostimulation system

Blistim System

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 3.
• 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
• Coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period.
• Concurrent participation in another clinical study
• Planned pregnancy, pregnancy, or breastfeeding.

Sponsors & Collaborators

• Man and Science, SA: lead

Study Sites (1)

VITAZ Hospital

Sint-Niklaas, Belgium

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• J-P Van Buyten

  VITAZ Hospital, Sint Niklaas, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 9, 2023
• Study Start: October 19, 2023
• Primary Completion: November 21, 2024
• Study Completion: March 30, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)