Migraine Prevention Using ActiPatch

NCT ID: NCT03166046

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-04-30

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Study Group

Subjects will use the active pulsed shortwave therapy device (ActiPatch) as a prophylactic treatment for episodic migraine

Group Type: ACTIVE_COMPARATOR

Pulsed Shortwave Therapy

Intervention Type: DEVICE

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

Control Group

Subjects will use the placebo pulsed shortwave therapy device (Placebo ActiPatch) as a prophylactic treatment for episodic migraine

Group Type: PLACEBO_COMPARATOR

Placebo Pulsed Shortwave therapy

Intervention Type: DEVICE

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

Interventions

Pulsed Shortwave Therapy

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

Intervention Type: DEVICE

Placebo Pulsed Shortwave therapy

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

Intervention Type: DEVICE

Other Intervention Names

ActiPatch; Placebo ActiPatch

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioElectronics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sree Koneru, Ph.D.

Role: STUDY_DIRECTOR

BioElectronics Corporation

Barry Eppley, MD

Role: PRINCIPAL_INVESTIGATOR

Eppley Group

Ian Rawe, Ph.D.

Role: STUDY_CHAIR

BioElectronics Corporation

Locations

Eppley Group

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

SAIRB-17-0021

Identifier Type: -

Identifier Source: org_study_id