Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-01
2028-06-01
Brief Summary
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Participants will be asked to keep a headache diary, then have the device implanted and programmed, and keep a subsequent headache diary to see if there is an improvement in their headaches after three moths of stimulation. If they don't respond to treatment, they will be allowed to swap to the other type of stimulation to see if this improves their symptoms.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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ONS using tonic stimulation with Prodigy Internal Pulse Generator
Tonic stimulation provides continuous electrical stimulation with perceptible paraesthesia to the occipital region. It is the standard of care at present in this unit and in most published studies of ONS.
Prodigy internal pulse generator occipital nerve stimulator
Electrical stimulation of the occipital nerves using an implantable device
ONS using BurstDR microdosing stimulation with Prodigy Internal Pulse Generator
BurstDR microdosing provides pulses of stimulation at a lower amplitude but higher frequency and a larger pulse width than Tonic stimulation. The stimulation is not perceptible to the patient and there is no paraesthesia. Early reports of spinal cord stimulation and suggest it may be preferable for patients and does not have any serious adverse effects.
Prodigy internal pulse generator occipital nerve stimulator
Electrical stimulation of the occipital nerves using an implantable device
Interventions
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Prodigy internal pulse generator occipital nerve stimulator
Electrical stimulation of the occipital nerves using an implantable device
Eligibility Criteria
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Inclusion Criteria
Subject should have failed to gain benefit from at least 4 classes of oral preventative medications, Botulinum toxin or acupuncture as defined by NHS (National Health Service) England Subject has been diagnosed at least 6 months prior to study enrolment with migraine headache with or without aura according to the ICHD-3 criteria 1.1, 1.2.1, or 1.3.
Subject is able to distinguish migraine attacks from other headaches (e.g. tension type headache, cluster headaches).
Subject agrees to not participate in supplemental or alternative therapy through the Follow Up Period of the study. This includes acupuncture, spinal manipulation, TENS (transcutaneous electrical nerve stimulation), and magnetic fields treatments.
Subject has the ability to read, comprehend, and to reliably record information as required by the Protocol.
Subject is able to provide written informed consent prior to participation in the study.
Exclusion Criteria
Subject has clinically significant drug (including opioid) or alcohol abuse as defined by DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision), will likely be unable to refrain from substance abuse throughout the study, has another significant pain problem, substance abuse or active depressive episode that might confound the study assessments in the opinion of the Investigator.
Subject is currently participating or has participated in the last month in another clinical study in which the subject has, is, or will be exposed to, an investigational drug or device, except for sponsor-related studies.
Subject is felt to be at risk of non-compliance (e.g., for completing the diary/questionnaires or returning for required follow-up visits) in the Investigator's opinion.
Subject has medication overuse headache which has not been managed (by withdrawal of the causative medication).
Subject is a woman of childbearing potential who is pregnant, nursing, or not using effective contraception.
Subject has an active implantable device such as pacemaker/ defibrillator or other neurostimulation device.
Subject has a history of bleeding disorders or coagulopathy or is unable to discontinue anticoagulation, antiplatelet, or GP (glycoprotein) IIb IIIa inhibitor medication in preparation for the implantation procedure.
Subject is not suitable for the study for any reason in the judgment of the Investigator.
18 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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IRAS 321114
Identifier Type: -
Identifier Source: org_study_id
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