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Migraine Prevention Using ActiPatch

NCT03166046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-08-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Pulsed Shortwave Therapy

Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.

DEVICE

Placebo Pulsed Shortwave therapy

Placebo Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.

Sponsors & Collaborators

  • BioElectronics Corporation

    lead INDUSTRY

Principal Investigators

  • Sree Koneru, Ph.D. · BioElectronics Corporation

  • Barry Eppley, MD · Eppley Group

  • Ian Rawe, Ph.D. · BioElectronics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-04-01
Completion
2018-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03166046 on ClinicalTrials.gov