Migraine Prevention Using ActiPatch
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Pulsed Shortwave Therapy; Placebo Pulsed Shortwave therapy
Intervention type(s): Device; Device
Intervention description(s): Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.; Placebo Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.
Other intervention name(s): ActiPatch; Placebo ActiPatch
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blind, placebo controlled trial using an active pulsed shortwave therapy device or placebo pulsed shortwave therapy device
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment