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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Active Comparator | Subjects will use the active pulsed shortwave therapy device (ActiPatch) as a prophylactic treatment for episodic migraine |
|
| Control Group | Placebo Comparator | Subjects will use the placebo pulsed shortwave therapy device (Placebo ActiPatch) as a prophylactic treatment for episodic migraine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Shortwave Therapy | Device | Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migraine frequency | frequency of migraine attacks | 4 weeks |
| Migraine duration | Duration of migraine attacks | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine intensity measured with Visual Analogue Pain Score | Migraine intensity measured with visual analogue pain score (VAS scores) | 4 weeks |
| Headache disability measured with Headache Impact Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sree Koneru, Ph.D. | BioElectronics Corporation | Study Director |
| Barry Eppley, MD | Eppley Group | Principal Investigator |
| Ian Rawe, Ph.D. | BioElectronics Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eppley Group | Indianapolis | Indiana | 46032 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Randomized, double blind, placebo controlled trial using an active pulsed shortwave therapy device or placebo pulsed shortwave therapy device
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Coded devices that are identical in appearance and function. Placebo device does not emit electromagnetic field. Active device electromagnetic field is sub-sensory.
| Placebo Pulsed Shortwave therapy | Device | Placebo Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve. |
|
|
Headache impact test (HIT-6)
| 4 weeks |
| D009422 | Nervous System Diseases |