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Pathway M-1: Sphenopalatine Ganglion Stimulation for the Treatment of Chronic or High Frequency, High Disability Migraine Headache

18 Years
Open (Enrolling)
Chronic Migraine, High Frequency, High Disability Migraine

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Trial Information

Pathway M-1: Sphenopalatine Ganglion Stimulation for the Treatment of Chronic or High Frequency, High Disability Migraine Headache

Inclusion Criteria:

- Age from >= 18 years old.

- Subject has been diagnosed with migraine headache with or without aura according to
the 2004 ICHD-II criteria 1.1 or 1.2.1 or chronic migraine according to 2006 ICHD-IIR
Appendix 1.5.1 .

- Subject reports at least 75% of migraine attacks having predominantly fixed (non
side-shifting) unilateral temporal or ocular pain, with a preference that the subject
reports associated cranial autonomic symptoms.

- Subject reports a minimum of 8 days per month with migraine attacks of at least
moderate severity based on the subject/Investigator's knowledge for at least 3 months
prior to inclusion and confirmed in a diary for at least 1 month (4 weeks) prior to

- Subject reports a minimum of 4 migraine attacks per month.

- Subject reports at least 24 hours of pain free periods between typical migraine
attacks, and at least 4 migraine-free days per month.

- Subject has a MIDAS score of III or IV, or has a HIT-6 score > 56.

- Subject is medically intractable in the opinion of the Investigator.

- Subject has had stable type and dosage of prophylactic headache medications for at
least 1 month prior to study enrollment and agrees to maintain stable type and dosage
of prophylactic headache medications through the completion of the Experimental

- Subject is able to distinguish migraine attacks from other headaches (i.e., TTH).

- Subject agrees to not participate in supplemental or alternative therapy during the
study. This includes: acupuncture, spinal manipulation, TENS, and magnetic fields

- 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

Exclusion Criteria:

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

- Subject currently has Medication Overuse Headache (MOH) according to the ICHD-IIR
2006 criteria.

- Subject reports continuous daily headaches for one month or longer at time of

- Subject reports initial onset of migraines within the last year.

- Subject has undergone facial surgery in the area of the pterygopalatine fossa or
zygomaticomaxillary buttress ipsilateral to the planned implant site that, in the
opinion of the Investigator, may lead to the inability to properly implant the

- Subject has active oral or dental abscess.

- Subject has been treated with radiation to the facial region.

- Subject has been diagnosed with any major infectious processes such as osteomyelitis,
or primary or secondary malignancies involving the face that have been active or
required treatment in the past 6 months or requires periodic MRI follow-up.

- Subject's pterygomaxillary fissure is less than 1.2 mm in width at the level of the
vidian canal, as determined by CT scan.

- Subject has clinically significant drug (including opioid) or alcohol abuse as
defined by DSM-IV-TR, will likely be unable to refrain from substance abuse
throughout the study, has other significant pain problem, substance abuse or active
depressive episode that might confound the study assessments in the opinion of the

- 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.

- Subject is felt to be at risk of non-compliance (e.g., for completing the diary or
maintaining a stable headache medicine regimen or returning for required follow-up
visits) in the Investigator's opinion.

- Subject is a woman of childbearing age who is pregnant, nursing, or not using

- Subject has had previous lesional radiofrequency ablation of the ipsilateral
sphenopalatine ganglion (SPG).

- Subject has had blocks or nonlesional pulsed RF of the ipsilateral SPG in the last 3

- Subject has undergone botulinium toxin injections of the head and/or neck in the last
3 months.

- Subject has or requires a pacemaker/defibrillator or other implantable device having
a sense amplifier that is programmed 'On.'

- Subject has a history of bleeding disorders or coagulopathy or is unable to
discontinue anticoagulation, antiplatelet, or GP 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Major Device- and Surgical-Related Complications

Outcome Description:

Occurrence rate of death, any surgery or hospitalization due to deterioration in subject health, or other Major Device-related Adverse Events

Outcome Time Frame:

Implantation through completion of Experimental Period (between 14 and 22 weeks following the implantation procedure)

Safety Issue:


Principal Investigator

Rigmor Jensen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Danish Headache Center, Glostrup Hospital


Denmark: Danish Medicines Agency

Study ID:

Pathway M-1 (CIP-003)



Start Date:

February 2012

Completion Date:

September 2015

Related Keywords:

  • Chronic Migraine
  • High Frequency, High Disability Migraine
  • Migraine
  • Chronic migraine
  • High frequency migraine
  • High disability migraine
  • Sphenopalatine ganglion
  • Neuromodulation
  • Neurostimulation
  • Autonomic nervous system
  • Synovial Cyst
  • Ganglion Cysts
  • Headache
  • Migraine Disorders