Migraine Prevention Using ActiPatch

NCT03166046 | Completed FDA Device

• 1 other identifier: SAIRB-17-0021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Migraine frequency

  frequency of migraine attacks

  4 weeks

• Migraine duration

  Duration of migraine attacks

  4 weeks

Secondary Outcomes (2)

• Migraine intensity measured with Visual Analogue Pain Score

  4 weeks

• Headache disability measured with Headache Impact Test

  4 weeks

Study Arms (2)

Study Group

ACTIVE COMPARATOR

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

Device: Pulsed Shortwave Therapy

Control Group

PLACEBO COMPARATOR

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

Device: Placebo Pulsed Shortwave therapy

Interventions

Pulsed Shortwave Therapy DEVICE

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

Also known as: ActiPatch

Study Group

Placebo Pulsed Shortwave therapy DEVICE

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

Also known as: Placebo ActiPatch

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• or greater occurrences of migraine per month
• no prior use of neuromodulation for migraine headache

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioElectronics Corporation: lead

Study Sites (1)

Eppley Group

Indianapolis, Indiana, 46032, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Sree Koneru, Ph.D.

  BioElectronics Corporation

  STUDY DIRECTOR

• Barry Eppley, MD

  Eppley Group

  PRINCIPAL INVESTIGATOR

• Ian Rawe, Ph.D.

  BioElectronics Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Coded devices that are identical in appearance and function. Placebo device does not emit electromagnetic field. Active device electromagnetic field is sub-sensory.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, placebo controlled trial using an active pulsed shortwave therapy device or placebo pulsed shortwave therapy device

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: June 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 30, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)