Migraine HeadacheNCT01294046
Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
A study testing Deep Brain Stimulation of SPG for Migraine in people with Migraine Headache, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This investigation will gather information about a procedure called sphenopalatine ganglion (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who suffer migraine headaches which may result in chronic severe disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Deep Brain Stimulation of SPG for Migraine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Subject has onset of migraine headache occurring before age 60.
- Subject has been diagnosed with migraine headache with or without aura, according to the 2004 IHS criteria 1.1 and 1.2.
- Subject reports a HIT-6 score of >56, a MIDAS score of >20 and/or a failure of adequate and appropriate previous migraine treatment.
- Subject has carried the diagnosis of migraine for at least 6 months prior to enrollment.
- Subject has had at least three migraine headache attacks per month.
Show all 12Show fewer
- Subject has had at least three headache days (migraine or non-migraine) per month and maintains this requirement during the baseline period on diary.
- Subject is able to distinguish migraine headache attacks as discrete from other headaches (i.e., tension-type headaches).
- Subject has the ability to read, comprehend and legibly and reliably record information as required by the protocol.
- Subject is able to provide written informed consent prior to participation in the study.
- Subject agrees to not participate in supplemental or alternative therapy during the baseline or treatment phases of the clinical study. This includes: acupuncture, spinal manipulation, TENS, and magnetic field treatments.
- Subject agrees to maintain current preventative headache medication regimens (no change in type, frequency, or dose) from baseline screening visit to the end of the Phase 2 treatment phase.
Who cannot join
- Subject currently has Medication Overuse Headache (MOH) in the judgment of the investigator or by ICHD-II criteria.
- Subject has a history of headaches days ≥ 15 per month.
- Subject has a history of trigeminal autonomic cephalalgias.
- Subject has any medical condition or disorder that:
- Is considered to be clinically significant and may pose a safety concern
- Could interfere with the accurate assessment of safety or efficacy
Show all 27Show fewer
- Could potentially affect a subject's safety or study outcome.
- Subject has had a major infection or surgery in the past month.
- Subject has undergone facial surgery in the area of sphenopalatine ganglia for cosmetic, corrective, therapeutic, or traumatic reasons.
- Subject has been treated with radiation to the face.
- Subject was diagnosed with any major infectious processes, primary or secondary malignancies involving the face that have been active or required treatment in the past six (6) months.
- Subject currently meets criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for an active major depressive episode or for active significant psychiatric disorders, including dementia, uncontrolled general anxiety disorder, psychotic disorders or uncontrolled bipolar disorder. Exclusion criteria include: suicidality, active psychosis, untreated severe depression and/ or anxiety disorder, litigation, addiction, homicidal ideation, significant Axis II disorders and untreated sleep disorder.
- Subject currently has clinically significant drug or alcohol abuse as defined by DSM-IV-TR or is unable to refrain from substance abuse throughout the study.
- 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 or non-investigational drug or device.
- Subject is felt to be at risk of non-compliance (e.g. for completing the diary or maintaining a stable headache medicine regimen) in the investigator's opinion.
- Subject is woman of childbearing age who is pregnant, nursing, or not using contraception.
- Subject has had previous radio-frequency ablation of the SPG.
- Subject has had blocks of the SPG in last 3 months.
- Subject has undergone botulinum toxin injections of the head and/or neck in the last 3 months.
- Subject has an implantable stimulator or any implanted devices in the head and/or neck.
- Subject has H/O bleeding disorders or coagulopathy, or is on anticoagulation, antiplatelet, or GP IIb IIIa inhibitor medication.
- Subject has H/O malignancy or any other condition that requires MRI monitoring.
- Subject has or requires pacemaker/defibrillator.
- Subject is not suitable for the study, in the judgment of the Investigators, due to social, co-morbid psychological, and/or medical considerations.
- Subject has H/O stroke, cardiovascular disease, and/or epilepsy.
- Subject was on antipsychotic or antidepressant medications (except for migraine prevention) in the past 3 months prior to the study.
- Subject is allergic or has shown hypersensitivity to materials of the Medtronic components which come in contact with the body.
Trial locations and contacts
1 site in 1 country.
About this study
This investigation will gather information about a procedure called sphenopalatine ganglion (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who suffer migraine headaches which may result in chronic severe disability. The SPG is a small collection of nerve cells in the head, and is located near the base of the nose on either side. Participation involves the surgical implantation of an electrode (small electrical conductor) over the sphenopalatine ganglion. The electrode is connected to a stimulator which will enable treatment for migraine headaches. Tiny electrical current is delivered to the stimulator device by an internal pulse generator implanted in the area at the top of the chest, to stop the migraine headaches. The implant system will be controlled with a wireless remote provided after the implant procedure.
Participation will record headache diaries throughout the study, which will last approximately 8½ months, and a yearly visit annually for five years.
Read the detailed description
This application proposes a clinical study of electrical stimulation of the sphenopalatine ganglia (SPG) as a treatment for up to three individuals with episodic migraine headache. The present study is aimed at obtaining pilot data to guide a future controlled trial of this treatment modality. The study population will include individuals suffering from episodic migraine headaches with chronic severe disability, as demonstrated by the Migraine Disability Assessment Questionnaire (Lipton, 2000) and Headache Impact Test short form (HIT-6™) (Kosinski, 2003).
The treatment involves implantation of an electrode into the SPG. The electrode is connected subcutaneously to an infraclavicular stimulator (PrimeAdvanced™ 37702 Multi-program Neurostimulator System, Medtronic Inc., Minneapolis MN). Proper electrode placement will be verified using anatomic and physiologic techniques. Participants will receive the Medtronic Model 3389 or 3387 lead, or Medtronic subcompact lead Model 3776-45, 3776-60, or 3776-75. Stimulation will be delivered in a range of frequencies from 20 to 130 Hz, and pulse width from 60 to 450 μsec, and a titrated voltage. The voltages used for chronic stimulation may range up to the pulse generator maximum of 10.5 volts but are anticipated to generally be below 3 volts, keeping below the 30 µcoulomb/cm² charge density safety limit, and below the threshold for adverse stimulation-related effects. The minimum number of contacts on the quadripolar leads will be activated as necessary to produce a response.
The Prime Advanced neurostimulator to be used in this study allows the clinician to set all stimulation parameters including the maximum allowable amplitude. It is our responsibility to assure that appropriate stimulation parameters are used to result in appropriate electrical exposure charge density) below a 30 µC/cm2/phase limit. As is done with commercially available neurostimulators, during this study, we will utilize the charts presented in Figures 1 and 2 below to assist in selection of programming parameters, and this programming will be maintained by software controls within the neurostimulator.
For this exploratory study of 3 patients, the maximum electrical stimulating parameters, resulting electrical exposure (e.g., charge density), will be determined using the methods described above. It is our responsibility to assure that safe stimulation parameters are used at all times and that the maximum settings do not exceed the safety limits. Our plan is to begin with lead 3776 if possible, because it does not require an extra extension, but we would use 3387 or 3389 if clinically indicated.
The proposed study is a physician-sponsored research investigation of three patients, and the attention to stimulation parameters will be much greater than can be expected for a commercially released product. It is our responsibility within this investigational study to insure the selected stimulation parameters do not exceed the safety limit of 30μC/cm2/phase. Patients participating in the study will only be able to lower stimulation amplitudes, thereby keeping stimulation parameters BELOW any clinician set maximum. The only programs available to or accessible by the patients will maintain the previously described parameter set limitations. Thus, the programming of the Implantable Programmable Generator (IPG) will keep the three patients from stimulating outside or above the set and safe parameters.
The primary outcome measures for assessing the efficacy of migraine treatment will be a subject reported daily diary noting frequency and intensity of headaches. During this investigation we will obtain preliminary controlled data on the safety and efficacy of SPG stimulation for migraine treatment.
- Conditions
- Migraine Headache
- Being tested
- Deep Brain Stimulation of SPG for Migraine
- Keywords
- Episodic migraine headache
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation of SPG for MigraineDevice
Also called Medtronic 37702 PrimeAdvanced™
Deep Brain Stimulation of SPG for Migraine
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation of SPG for migraine | Experimental | Electrical SPG for Treatment of Migraine Receives: Device: Deep Brain Stimulation of SPG for Migraine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Relief at 2 Hours Post Stimulation
Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.
Measured: 8.5 Months
Secondary outcomes (9)
Migraine Free at 2 Hours
Each migraine will be categorized as meeting the endpoint of migraine free if there is a reduction in the migraine grade to 0 for pain with no nausea, photophobia and phonophobia at 2 hours after initiation of stimulation.
Measured: 8.5 Months
Pain Free at 2 Hours Post Stimulation
As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.
Measured: 8.5 months
Acute Migraine Medication Use
During the baseline period, subjects will record their acute as-needed migraine relief medication use for each attack by drug, dose, route, and frequency. A secondary endpoint for this phase is a reduction in acute migraine medication usage for each attack for drug, dose, route, and frequency during the last month of the study as compared to the baseline month.
Measured: 8.5 months
Headache Impact Test (HIT-6) Compared With Baseline
The Headache Impact Test -6 (HIT-6) is a validated tool for evaluating headache impact and disability across 6 domains, which will be recorded at baseline and at study conclusion.
Measured: 8.5 months
Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline
The Migraine Disability Assessment Scale (MIDAS) is a validated tool that assesses how many days in the last 3 months a patient had at least 50% disability at work, home, school, or recreational activities due to migraine. MIDAS will be assessed at baseline and after study conclusion.
Measured: 8.5 months
Stimulation Related Adverse Events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 8.5 months
Average Per Subject Reduction in Migraine Days/Month
During the baseline period, subjects will record the number of migraine days (as defined by the FDA-approved International Classification of Headache Disorders, 2d Edition definition of migraine with and without aura) during the month. The primary endpoint for this phase is a reduction in the number of migraine days during the last month of the study as compared to the baseline month.
Measured: 8.5 months
Implantation and Stimulation Related Adverse Events
As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.
Measured: 8.5 months
Relief of Migraine-associated Symptoms, e.g. Nausea/Vomiting, Photophobia, Phonophobia
Presence or absence of nausea, vomiting, photophobia, and phonophobia will be assessed at baseline and after stimulation at 2 hours for each stimulation for each individual.
Measured: 8.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Autonomic Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- Stewart J Tepper, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294046
- Sponsor's protocol ID
- IDE Number : G100007
- Status last verified
- Apr 2017
- First submitted
- 4 Feb 2011
- Last updated
- 14 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
- ClinicalTrials.gov ID
- NCT01294046
- Acronym / sponsor ID
- IDE Number : G100007
- Conditions
- Migraine Headache
- Keywords
- Episodic migraine headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Autonomic Technologies, Inc.
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 7 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation will gather information about a procedure called sphenopalatine ganglion (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who suffer migraine headaches which may result in chronic severe disability. The SPG is a small collection of nerve cells in the head, and is located near the base of the nose on either side. Participation involves the surgical implantation of an electrode (small electrical conductor) over the sphenopalatine ganglion. The electrode is connected to a stimulator which will enable treatment for migraine headaches. Tiny electrical current is delivered to the stimulator device by an internal pulse generator implanted in the area at the top of the chest, to stop the migraine headaches. The implant system will be controlled with a wireless remote provided after the implant procedure.
Participation will record headache diaries throughout the study, which will last approximately 8½ months, and a yearly visit annually for five years.
Detailed description
This application proposes a clinical study of electrical stimulation of the sphenopalatine ganglia (SPG) as a treatment for up to three individuals with episodic migraine headache. The present study is aimed at obtaining pilot data to guide a future controlled trial of this treatment modality. The study population will include individuals suffering from episodic migraine headaches with chronic severe disability, as demonstrated by the Migraine Disability Assessment Questionnaire (Lipton, 2000) and Headache Impact Test short form (HIT-6™) (Kosinski, 2003).
The treatment involves implantation of an electrode into the SPG. The electrode is connected subcutaneously to an infraclavicular stimulator (PrimeAdvanced™ 37702 Multi-program Neurostimulator System, Medtronic Inc., Minneapolis MN). Proper electrode placement will be verified using anatomic and physiologic techniques. Participants will receive the Medtronic Model 3389 or 3387 lead, or Medtronic subcompact lead Model 3776-45, 3776-60, or 3776-75. Stimulation will be delivered in a range of frequencies from 20 to 130 Hz, and pulse width from 60 to 450 μsec, and a titrated voltage. The voltages used for chronic stimulation may range up to the pulse generator maximum of 10.5 volts but are anticipated to generally be below 3 volts, keeping below the 30 µcoulomb/cm² charge density safety limit, and below the threshold for adverse stimulation-related effects. The minimum number of contacts on the quadripolar leads will be activated as necessary to produce a response.
The Prime Advanced neurostimulator to be used in this study allows the clinician to set all stimulation parameters including the maximum allowable amplitude. It is our responsibility to assure that appropriate stimulation parameters are used to result in appropriate electrical exposure charge density) below a 30 µC/cm2/phase limit. As is done with commercially available neurostimulators, during this study, we will utilize the charts presented in Figures 1 and 2 below to assist in selection of programming parameters, and this programming will be maintained by software controls within the neurostimulator.
For this exploratory study of 3 patients, the maximum electrical stimulating parameters, resulting electrical exposure (e.g., charge density), will be determined using the methods described above. It is our responsibility to assure that safe stimulation parameters are used at all times and that the maximum settings do not exceed the safety limits. Our plan is to begin with lead 3776 if possible, because it does not require an extra extension, but we would use 3387 or 3389 if clinically indicated.
The proposed study is a physician-sponsored research investigation of three patients, and the attention to stimulation parameters will be much greater than can be expected for a commercially released product. It is our responsibility within this investigational study to insure the selected stimulation parameters do not exceed the safety limit of 30μC/cm2/phase. Patients participating in the study will only be able to lower stimulation amplitudes, thereby keeping stimulation parameters BELOW any clinician set maximum. The only programs available to or accessible by the patients will maintain the previously described parameter set limitations. Thus, the programming of the Implantable Programmable Generator (IPG) will keep the three patients from stimulating outside or above the set and safe parameters.
The primary outcome measures for assessing the efficacy of migraine treatment will be a subject reported daily diary noting frequency and intensity of headaches. During this investigation we will obtain preliminary controlled data on the safety and efficacy of SPG stimulation for migraine treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulation of SPG for migraine | Experimental | Device: Deep Brain Stimulation of SPG for MigraineElectrical SPG for Treatment of Migraine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years.
- Subject has onset of migraine headache occurring before age 60.
- Subject has been diagnosed with migraine headache with or without aura, according to the 2004 IHS criteria 1.1 and 1.2.
- Subject reports a HIT-6 score of >56, a MIDAS score of >20 and/or a failure of adequate and appropriate previous migraine treatment.
- Subject has carried the diagnosis of migraine for at least 6 months prior to enrollment.
Key exclusion criteria (27 listed)
- Subject currently has Medication Overuse Headache (MOH) in the judgment of the investigator or by ICHD-II criteria.
- Subject has a history of headaches days ≥ 15 per month.
- Subject has a history of trigeminal autonomic cephalalgias.
- Subject has any medical condition or disorder that:
- Subject has had a major infection or surgery in the past month.
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 |
|---|---|---|
| Deep Brain Stimulation of SPG for MigraineAlso: Medtronic 37702 PrimeAdvanced™Deep Brain Stimulation of SPG for Migraine | Device | Deep brain stimulation of SPG for migraine |
Primary outcome
Migraine Relief at 2 Hours Post Stimulation
Time frame: 8.5 Months
Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.
9 secondary outcomes
Migraine Free at 2 Hours
Time frame: 8.5 Months
Pain Free at 2 Hours Post Stimulation
Time frame: 8.5 months
Acute Migraine Medication Use
Time frame: 8.5 months
Headache Impact Test (HIT-6) Compared With Baseline
Time frame: 8.5 months
Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline
Time frame: 8.5 months
Stimulation Related Adverse Events
Time frame: 8.5 months
Average Per Subject Reduction in Migraine Days/Month
Time frame: 8.5 months
Implantation and Stimulation Related Adverse Events
Time frame: 8.5 months
Relief of Migraine-associated Symptoms, e.g. Nausea/Vomiting, Photophobia, Phonophobia
Time frame: 8.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stewart J Tepper, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation of SPG for Migraine in people with Migraine Headache, run by The Cleveland Clinic at 1 site in United States.
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 12 inclusion and 27 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: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 7 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine Relief at 2 Hours Post Stimulation (time frame: 8.5 Months). 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 14 Apr 2017.