Occipital Nerve Stimulation in Chronic Migraine

Official title

A Prospective, Randomised, Open Label Feasibility Trial Comparing BurstDR Microdosing Versus Tonic Occipital Nerve Stimulation for Patients With Refractory Chronic Migraine

Overview

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.

Detailed description

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.

Interventions

• Device Prodigy internal pulse generator occipital nerve stimulator
  Electrical stimulation of the occipital nerves using an implantable device

Primary outcome measures

• Efficacy of ONS [Time frame: 3 months post activation of ONS]

Secondary outcome measures (11)

• Number and severity of adverse events with Tonic and BurstDR stimulation [Time frame: 1,3,6 months compared to baseline]
• 30% responder rate [Time frame: 1,3,6 months compared to baseline]
• Monthly migraine days [Time frame: 1,3,6 months compared to baseline]
• Monthly moderate to severe headache days [Time frame: 6,9,12 months post activation]
• Headache severity [Time frame: 1,3,6 months compared to baseline]
• Change in mean monthly headache load [Time frame: At 1, 3, 6 months post activation]
• HIT-6 score (Headache Impact Test - 6) [Time frame: 1,3 and 6 months post activation]
• MIDAS (migraine disability assessment) score [Time frame: 1,3 and 6 months post activation]
• Hospital anxiety scores (HADS-A) [Time frame: 1,3 and 6 months post activation]
• Hospital depression score (HADS-D) [Time frame: 1,3 and 6 months post activation]
• Change in EuroQol-5D5L (European Quality of Life 5 Dimensions) score [Time frame: 1,3,6 months compared to baseline]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07087678 · IRAS 321114

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗