Occipital Nerve Stimulation in Chronic Migraine

NCT07087678 | Not Yet Recruiting FDA Device

• 1 other identifier: IRAS 321114
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare two different types of occipital nerve stimulation (BurstDR (dorsal root) microdosing versus Tonic) in chronic refractory migraine. The main questions it aims to answer is whether BurstDR microdosing is effective in reducing moderate to severe headache days compared to Tonic stimulation (which is currently in use). Additionally, the safety of both types of stimulation will be studied. 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.

Conditions

Chronic Migraine, Headache; Refractory Migraine

Keywords

Chronic migraine; Occipital nerve stimulation; BurstDR microdosing; Refractory migraine

Outcome Measures

Primary Outcomes (1)

• Efficacy of ONS

  The primary objective is to compare the reduction in moderate to severe headache days at three months (i.e. weeks 8-12 post activation of the ONS device) in patients who have tonic stimulation compared to those having BurstDR stimulation. Severity of headache will be recorded on a 0-10 pain scale in a daily in a headache diary which is completed by the patient throughout the baseline and intervention period. Moderate to severe headache days are defined as: a 24-hour period with headache pain of moderate or severe intensity that lasts at least 4 hours without medication, or a day with a headache pain of at least moderate intensity that responds to acute treatment with a migraine-specific medication. On the pain scale, 1-3/10 equates to mild pain, 4-6/10 equates to moderate pain and 7-10/10 equates to severe pain.

  3 months post activation of ONS

Secondary Outcomes (11)

• Number and severity of adverse events with Tonic and BurstDR stimulation

  1,3,6 months compared to baseline

• 30% responder rate

  1,3,6 months compared to baseline

• Monthly migraine days

  1,3,6 months compared to baseline

• Monthly moderate to severe headache days

  6,9,12 months post activation

• Headache severity

  1,3,6 months compared to baseline

Study Arms (2)

ONS using tonic stimulation with Prodigy Internal Pulse Generator

ACTIVE COMPARATOR

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.

Device: Prodigy internal pulse generator occipital nerve stimulator

ONS using BurstDR microdosing stimulation with Prodigy Internal Pulse Generator

EXPERIMENTAL

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.

Device: Prodigy internal pulse generator occipital nerve stimulator

Interventions

Prodigy internal pulse generator occipital nerve stimulator DEVICE

Electrical stimulation of the occipital nerves using an implantable device

ONS using BurstDR microdosing stimulation with Prodigy Internal Pulse Generator; ONS using tonic stimulation with Prodigy Internal Pulse Generator

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old and diagnosed with intractable chronic migraine by a headache specialist, as defined by the International Classification of Headache Disorders-3 (ICHD-3).
• 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.

You may not qualify if:

• Subject's overall health, age and/or comorbidities place subject at high risk for complications from surgery and/or general anaesthesia.
• 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.

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Conditions

Headache; Migraine Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Manjit Matharu, BSc, MBChB, PhD, FRCP

CONTACT

+44020 3448 3664; manjit.matharu@ucl.ac.uk

Lucy Simmonds, BMedSci, BMBS, MRCP

CONTACT

lucysimmonds@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible subjects will complete a baseline headache diary and questionnaires, and then be randomised to BurstDR microdosing or tonic stimulation. After implantation and stabilisation, the device is activated and they continue to complete headache diary and questionnaires at 1 month, 3 months and 6 months whilst further programming optimisation occurs. Non-responders are offered the opportunity to cross over into the opposite arm. Further diary and questionnaire monitoring will occur at 1 year and optional long term follow up at 2 years.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: July 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share