Migraine Prevention Using ActiPatch (PSWT)

• ClinicalTrials.gov Identifier: NCT03166046
• Recruitment Status: Completed
• First Posted: May 24, 2017
• Last Update Posted: August 2, 2018
• Sponsor: BioElectronics Corporation
• Information provided by (Responsible Party): BioElectronics Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Migraine	Device: Pulsed Shortwave Therapy; Device: Placebo Pulsed Shortwave therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• 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)
• 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.
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Migraine frequency [ Time Frame: 4 weeks ]
   frequency of migraine attacks
2. Migraine duration [ Time Frame: 4 weeks ]
   Duration of migraine attacks

Secondary Outcome Measures :

1. Migraine intensity measured with Visual Analogue Pain Score [ Time Frame: 4 weeks ]
   Migraine intensity measured with visual analogue pain score (VAS scores)
2. Headache disability measured with Headache Impact Test [ Time Frame: 4 weeks ]
   Headache impact test (HIT-6)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Indiana

Eppley Group

Indianapolis, Indiana, United States, 46032

Sponsors and Collaborators

BioElectronics Corporation

Investigators

• Study Director: Sree Koneru, Ph.D.; BioElectronics Corporation
• Principal Investigator: Barry Eppley, MD; Eppley Group
• Study Chair: Ian Rawe, Ph.D.; BioElectronics Corporation

More Information

• Responsible Party: BioElectronics Corporation
• ClinicalTrials.gov Identifier: NCT03166046
• Other Study ID Numbers: SAIRB-17-0021
• First Posted: May 24, 2017
• Last Update Posted: August 2, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases