Chronic Migraine, HeadacheNCT07087678
Occipital Nerve Stimulation in Chronic Migraine
A study testing Prodigy internal pulse generator occipital nerve stimulator in people with Chronic Migraine, Headache and Refractory Migraine, run by University College, London.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine, Headache, Refractory Migraine
- What is being tested?
- Prodigy internal pulse generator occipital nerve stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lucy Simmonds, BMedSci, BMBS, MRCP contact
About this study
Official title: A Prospective, Randomised, Open Label Feasibility Trial Comparing BurstDR Microdosing Versus Tonic Occipital Nerve Stimulation for Patients With Refractory Chronic Migraine
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.
Read the 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.
- Conditions
- Chronic Migraine, Headache, Refractory Migraine
- Being tested
- Prodigy internal pulse generator occipital nerve stimulator
- Keywords
- Chronic migraine, Occipital nerve stimulation, BurstDR microdosing, Refractory migraine
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prodigy internal pulse generator occipital nerve stimulatorDevice
Electrical stimulation of the occipital nerves using an implantable device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Prodigy internal pulse generator occipital nerve stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post activation of ONS
Secondary outcomes (11)
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
Measured: 1,3,6 months compared to baseline
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
Measured: 1,3,6 months compared to baseline
Monthly migraine days
Change in monthly migraine days
Measured: 1,3,6 months compared to baseline
Monthly moderate to severe headache days
Change in monthly moderate to severe headache days compared to baseline
Measured: 6,9,12 months post activation
Headache severity
Change in monthly mean headache severity compared to baseline
The pain scale described in the primary outcome measure will be applied here.
Measured: 1,3,6 months compared to baseline
Change in mean monthly headache load
Headache load is calculated as the sum of the product of pain severity (on 0-10 scale), headache duration in hours for each attack over a 28 day period.
A lower headache load equates to a better outcome.
Measured: At 1, 3, 6 months post activation
HIT-6 score (Headache Impact Test - 6)
Change in mean HIT-6 score compared to baseline
A lower HIT-6 score equates to a better outcome. The minimum value is 36 and the maximum value is 78.
Measured: 1,3 and 6 months post activation
MIDAS (migraine disability assessment) score
Change in MIDAS score compared to baseline
A lower score equates to a better outcome. The minimum value is 0 and the maximum value is 270.
Measured: 1,3 and 6 months post activation
Hospital anxiety scores (HADS-A)
Change in HADS-A compared to baseline A lower score equates to a better outcome. The minimum score is 0 and the maximum is 21.
Measured: 1,3 and 6 months post activation
Hospital depression score (HADS-D)
Change in HADS-D compared to baseline
A lower score equates to a better outcome. The minimum score is 0 and the maximum is 21.
Measured: 1,3 and 6 months post activation
Change in EuroQol-5D5L (European Quality of Life 5 Dimensions) score
The EuroQol-5D5DL score measures quality of life in dimensions of life activities, and includes a global rating of their overall health.
Measured: 1,3,6 months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine, HeadacheStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087678
- Sponsor's protocol ID
- IRAS 321114
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymised participant-level dataset may be made available on request for clinical or academic purposes only, after publication of the trial results.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Open Label Feasibility Trial Comparing BurstDR Microdosing Versus Tonic Occipital Nerve Stimulation for Patients With Refractory Chronic Migraine
- ClinicalTrials.gov ID
- NCT07087678
- Acronym / sponsor ID
- IRAS 321114
- Conditions
- Chronic Migraine, Headache, Refractory Migraine
- Keywords
- Chronic migraine, Occipital nerve stimulation, BurstDR microdosing, Refractory migraine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| ONS using tonic stimulation with Prodigy Internal Pulse Generator | Active comparator | Device: Prodigy internal pulse generator occipital nerve stimulatorTonic 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. |
| ONS using BurstDR microdosing stimulation with Prodigy Internal Pulse Generator | Experimental | Device: Prodigy internal pulse generator occipital nerve stimulatorBurstDR 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prodigy internal pulse generator occipital nerve stimulatorElectrical stimulation of the occipital nerves using an implantable device | Device | ONS using BurstDR microdosing stimulation with Prodigy Internal Pulse Generator, ONS using tonic stimulation with Prodigy Internal Pulse Generator |
Primary outcome
Efficacy of ONS
Time frame: 3 months post activation 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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes. Anonymised participant-level dataset may be made available on request for clinical or academic purposes only, after publication of the trial results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucy Simmonds, BMedSci, BMBS, MRCP contact
Questions about this trial
What is this clinical trial studying?
A study testing Prodigy internal pulse generator occipital nerve stimulator in people with Chronic Migraine, Headache and Refractory Migraine, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manjit Matharu, BSc, MBChB, PhD, FRCP (+44020 3448 3664, manjit.matharu@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of ONS (time frame: 3 months post activation of ONS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.