Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine

NCT04194008 | Completed Results DMC FDA Device

• 1 other identifier: TCH006
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 10

Brief Summary

A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases: Phase I - Run-in: Eligible participants will be trained to use a smartphone migraine diary application. During the 4 weeks of this phase, participants will be instructed to report all their migraines and headaches at onset, 2 hours and 24 hours post report . Phase II - Treatment: A 4-week treatment phase in which participants will be asked to treat their migraine headaches with the Nerivio device and report it using the smartphone application at baseline, 2 hours and 24 hours post-treatment. Phase III - Follow-up: An 8-week follow-up phase in which participants will incorporate the Nerivio device into their usual care according to their preference (Nerivio only, medication only, both or none). Participants will be asked to report all their migraines or headaches at onset, 2 hours post report and 24 hours post report.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• Pain Relief at 2 Hours Post-treatment

  The proportion of subjects reporting, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)

  2 hours post-treatment

Secondary Outcomes (4)

• Pain-free at 2 Hours Post-treatment

  2 hours post-treatment

• Disappearance of Nausea at 2 Hours Post-treatment

  2 hours post treatment

• Disappearance of Photophobia at 2 Hours Post-treatment

  2 hours post treatment

• Disappearance of Phonophobia at 2 Hours Post-treatment

  2 hours post treatment

Other Outcomes (4)

• Within-subject Consistency of the Pain Relief Response

  throughout the study

• Functional Disability at 2 Hours Post-treatment

  2 hours post treatment

• Functional Disability at 24 Hours Post-treatment

  24 hours post treatment

Study Arms (1)

Nerivio device treatment

EXPERIMENTAL

Treatment with active Nerivio device

Device: Nerivio

Interventions

Nerivio DEVICE

A remote electrical neuromodulation (REN) device for the acute treatment of migraines.The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.

Nerivio device treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18-75 years old.
• Participants meeting the International Classification of Headache Disorders-3 (ICHD-3) diagnostic criteria for chronic migraine
• Participants experiencing between 15 to 23 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation
• Participants have personal access to a smartphone
• Participants must be able and willing to comply with the protocol
• Participants must be able and willing to provide written informed consent

You may not qualify if:

• Participants with an active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
• Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
• Participants with uncontrolled epilepsy.
• Lack of efficacy, after an adequate therapeutic trial, of at least two migraine specific acute medications.
• Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study
• Pregnant, trying to get pregnant or breastfeeding female participants
• Subjects participating in any other interventional clinical study.
• Participants without basic cognitive and/or motor skills needed to operate a smartphone
• Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
• Participants who have previous experience with the device

Sponsors & Collaborators

• Theranica: lead

Study Sites (10)

Newport Beach Clinical Research Associates, Inc.

Newport Beach, California, 92663, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Hartford Healthcare Center

Hartford, Connecticut, 06102, United States

Location

Headache Neurology Research Institute

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research, LLC

City of Saint Peters, Missouri, 63303, United States

Location

ClinVest

Springfield, Missouri, 65810, United States

Location

Mercy Hospital

St Louis, Missouri, 63141, United States

Location

Island Neurological

Plainview, New York, 11803, United States

Location

Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania, 15220, United States

Location

Nashville neuroscience

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Grosberg B, Rabany L, Lin T, Harris D, Vizel M, Ironi A, O'Carroll CP, Schim J. Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study. Pain Rep. 2021 Oct 14;6(4):e966. doi: 10.1097/PR9.0000000000000966. eCollection 2021 Nov-Dec.

  PMID: 34667919 DERIVED

Limitations and Caveats

No limitations or caveats were reported

Results Point of Contact

• Title: Dr Dagan Harris. VP Clinical & Regulatory Affairs
• Organization: Theranica Bio-Electronics Ltd

daganh@theranica.com

0542220121

Study Officials

• Brian Grosberg, MD

  Hartford Healthcare Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 11, 2019
• Study Start: November 18, 2019
• Primary Completion: May 22, 2020
• Study Completion: August 30, 2020
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)