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BONS: Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH

Sponsor
Man and Science, SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06124534
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
17.3
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Neurostimulation of the Occipital Nerve Field
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Bilateral Occipital Nerve Field Stimulation for the Prophylactic Treatment of Difficult-to-treat Chronic Cluster Headache
Actual Study Start Date :
Oct 19, 2023
Anticipated Primary Completion Date :
Nov 21, 2024
Anticipated Study Completion Date :
Mar 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. Medication overuse headache (ICHD 3 8.2)

  2. Inability to fill out an electronic diary.

  3. Previous surgery or trauma involving the cervical spine or the occipital bone

  4. Coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period.

  5. Concurrent participation in another clinical study

  6. Planned pregnancy, pregnancy, or breastfeeding.

Contacts and Locations

Locations

Site City State Country Postal Code
1 VITAZ Hospital Sint-Niklaas Belgium

Sponsors and Collaborators

  • Man and Science, SA

Investigators

  • Principal Investigator: J-P Van Buyten, VITAZ Hospital, Sint Niklaas, Belgium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Man and Science, SA
ClinicalTrials.gov Identifier:
NCT06124534
Other Study ID Numbers:
  • DOC-130
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Man and Science, SA
Cluster Headaches
Additional relevant MeSH terms:
Cluster Headache
Headache

Study Results

No Results Posted as of Nov 13, 2023