Migraine Prevention Using ActiPatch
Migraine Prevention Using ActiPatch
Chronic pain is now widely understood to be due to central sensitization, which leads to
 exaggerated pain perception. Migraine is no exception, since it is well known that
 sensitization of the trigeminovascular pain pathway can occur during a migraine attach. There
 is early evidence that ActiPatch can help mitigate this sensitization, so this study is being
 conducted to determine the efficacy of ActiPatch in preventing chronic, episodic migraines.
Migraine is a common neurological disorder characterized by episodes of unilateral or
 bilateral headache lasting for hours to days, which may be accompanied by photophobia,
 phonophobia, nausea and vomiting. Pharmacological management is the first treatment option
 for subjects with migraine. However, some patients do not tolerate acute and/or prophylactic
 medicine due to side effects or contraindications due to comorbidity of other diseases or due
 to a wish to avoid medication for other reasons. The risk of medication overuse due to
 frequent migraine attacks represents a major health hazard with direct and indirect cost
 concerns. The prevalence of medication overuse headache is 1 -2% in the general population,
 that is, about half the population suffering chronic headache (15 headache days or more per
 month) have medication overuse headache.It is well-known that a primary brain dysfunction
 leads to episodic activation and sensitization of the trigeminovascular pain pathway during
 attacks. However, a functional and anatomic relationship exists between peripheral afferent
 nerves supplying the head and neck and the brainstem, subcortical and higher order brain
 processing centers. There is some evidence that interventions targeting peripheral nerves are
 able to modulate neuronal circuits involved in pain control and that they could be useful in
 some selected patients with migraine.

 Supraorbital neurostimulation (tSNS) of the upper branches of the trigeminal nerves was found
 superior to sham stimulation for episodic migraine prevention in a previous randomized trial
 in a large cohort of patients with migraine. In this study the pulsed shortwave device will
 be incorporated in a wrap which will enable easy placement of the device in the desired
 located which will be over the supratrochlear and supraorbital branches of the ophthalmic
 nerve.
Inclusion Criteria:

 -  Participant is willing and able to give informed consent for participation in the
 trial.

 -  In the Investigator's opinion, is able and willing to comply with all trial
 requirements.

 -  Male or female ages 18 or above with migraine headache

 -  3 or greater occurrences of migraine per month

 -  no prior use of neuromodulation for migraine headache

 Exclusion Criteria:

 -  Female participant who is pregnant

 -  prior use of neuromodulation for migraine headache

 -  Laminectomy, laminotomy or discectomy within 12 months of enrollment.

 -  Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication,
 bipolar disorder, schizophrenia).

 -  Patients diagnosed with history of significant mood disorder will be excluded (e.g.,
 depression or anxiety with adequate control would be acceptable).

 -  Scheduled elective surgery or other procedures requiring general anaesthesia during
 the trial.

 -  Any other significant disease or disorder which, in the opinion of the Investigator,
 may either put the participants at risk because of participation in the trial, or may
 influence the result of the trial, or the participant's ability to participate in the
 trial.

 -  Participants who have participated in another research trial involving an
 investigational product in the past 12 weeks.