Clinical trial NCT03166046: Migraine Prevention Using ActiPatch
Official title: Migraine Prevention Using Pulsed Shortwave Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: BioElectronics Corporation
Sponsor class: INDUSTRY
First posted: 2017-05-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, placebo controlled trial using an active pulsed shortwave therapy device or placebo pulsed shortwave therapy device
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Migraine frequency
timeFrame: 4 weeks
measure: Migraine duration
timeFrame: 4 weeks
Secondary outcomes:
measure: Migraine intensity measured with Visual Analogue Pain Score
timeFrame: 4 weeks
measure: Headache disability measured with Headache Impact Test
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eppley Group
state: Indiana
Study officials:
affiliation: BioElectronics Corporation
name: Sree Koneru, Ph.D.
role: STUDY_DIRECTOR
affiliation: Eppley Group
name: Barry Eppley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BioElectronics Corporation
name: Ian Rawe, Ph.D.
role: STUDY_CHAIR
References: