Migraine Prevention Using ActiPatch

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.