Migraine Prevention Using ActiPatch (PSWT)
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|ClinicalTrials.gov Identifier: NCT03166046|
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Device: Pulsed Shortwave Therapy Device: Placebo Pulsed Shortwave therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|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)|
|Masking Description:||Coded devices that are identical in appearance and function. Placebo device does not emit electromagnetic field. Active device electromagnetic field is sub-sensory.|
|Official Title:||Migraine Prevention Using Pulsed Shortwave Therapy|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||April 1, 2018|
|Actual Study Completion Date :||April 30, 2018|
Active Comparator: Study Group
Subjects will use the active pulsed shortwave therapy device (ActiPatch) as a prophylactic treatment for episodic migraine
Device: Pulsed Shortwave Therapy
Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.
Other Name: ActiPatch
Placebo Comparator: Control Group
Subjects will use the placebo pulsed shortwave therapy device (Placebo ActiPatch) as a prophylactic treatment for episodic migraine
Device: Placebo Pulsed Shortwave therapy
Placebo Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.
Other Name: Placebo ActiPatch
- Migraine frequency [ Time Frame: 4 weeks ]frequency of migraine attacks
- Migraine duration [ Time Frame: 4 weeks ]Duration of migraine attacks
- Migraine intensity measured with Visual Analogue Pain Score [ Time Frame: 4 weeks ]Migraine intensity measured with visual analogue pain score (VAS scores)
- Headache disability measured with Headache Impact Test [ Time Frame: 4 weeks ]Headache impact test (HIT-6)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166046
|United States, Indiana|
|Indianapolis, Indiana, United States, 46032|
|Study Director:||Sree Koneru, Ph.D.||BioElectronics Corporation|
|Principal Investigator:||Barry Eppley, MD||Eppley Group|
|Study Chair:||Ian Rawe, Ph.D.||BioElectronics Corporation|