Occipital Nerve Stimulation in Chronic Migraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Prodigy internal pulse generator occipital nerve stimulator
DeviceElectrical stimulation of the occipital nerves using an implantable device
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ONS using tonic stimulation with Prodigy Internal Pulse GeneratorActive comparator 1 intervention
Group B: ONS using BurstDR microdosing stimulation with Prodigy Internal Pulse GeneratorExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
3 months post activation of ONSSecondary outcomes
1
Number and severity of adverse events with Tonic and BurstDR stimulation
Adverse events (AEs) will be recorded for all patients at each follow up appointment (and in between appointments if appropriate). Each adverse event will be assessed for severity, causality, seriousness and expectedness. AEs will be recored from the time of ONS insertion until the end of the subject's involvement in the trial. Definitions: Mild AE: does not interfere with the participant's daily routine, and does not require further intervention; it causes slight discomfort Moderate AE: interferes with some aspects of the participant's routine, or requires further intervention, but is not damaging to health; it causes moderate discomfort Severe AE: results in alteration, discomfort or disability which is clearly damaging to health
Time frame
1,3,6 months compared to baseline2
30% responder rate
The proportion of subjects which achieve ≥30% reduction in headache load at one, three and six months compared to baseline) for tonic verses BurstDR microdosing
Time frame
1,3,6 months compared to baseline3
Monthly migraine days
Change in monthly migraine days
Time frame
1,3,6 months compared to baseline4
Monthly moderate to severe headache days
Change in monthly moderate to severe headache days compared to baseline
Time frame
6,9,12 months post activationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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