ClinicalTrials.gov Identifier: NCT03166046
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : May 16, 2018
(Thanks dblock110)
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
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
Go to sections
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
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Migraine
U.S. FDA Resources
Arms and Interventions
Go to sections
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
Go to sections
Primary Outcome Measures :
Migraine frequency [ Time Frame: 4 weeks ]
frequency of migraine attacks
Migraine duration [ Time Frame: 4 weeks ]
Duration of migraine attacks
Secondary Outcome Measures :
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)
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
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
Go to sections
Information from the National Library of Medicine
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
Locations
United States, Indiana
Eppley Group
Indianapolis, Indiana, United States, 46032
Sponsors and Collaborators
BioElectronics Corporation
More Information
Go to sections
Responsible Party: BioElectronics Corporation
ClinicalTrials.gov Identifier: NCT03166046 History of Changes
Other Study ID Numbers: SAIRB-17-0021
First Posted: May 24, 2017 Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2017
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
Device Product Not Approved or Cleared by U.S. FDA: No
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
IT IS WHAT IT IS NOTHING ELSE
