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

NCT04161807 | Completed Results FDA Device

• 1 other identifier: TCH005
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 2

Brief Summary

This study is intended to evaluate the efficacy and safety of Nerivio, an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine, for the acute treatment of migraine in people with chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The study duration consists of a 4 weeks of active treatment with the device in about 40 patients.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment

  The proportion of participants reporting pain relief at 2 hours post-treatment without the use of rescue medication following the test treatment . Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain.

  2 hours post-treatment

Secondary Outcomes (4)

• Proportion of Participants With Pain Disappearance at 2 Hours Post Treatment

  2 hours post treatment

• Proportion of Participants With Disappearance of Nausea and/or Vomiting at 2 Hours Post-treatment

  2 hours post treatment

• Proportion of Participants With Disappearance of Photophobia at 2 Hours Post-treatment

  2 hours post treatment

• Proportion of Participants With Disappearance of Phonophobia at 2 Hours Post-treatment

  2 hours post treatment

Other Outcomes (4)

• Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments

  4 weeks

• Within-patient Consistency - Percentage of Participants Free of Headache Pain in at Least 50% of Their Treatments

  4 weeks

• Proportion of Participants With Improve Functional Disability at 2 Hours Post-treatment

  2 hours post treatment

Study Arms (1)

Nerivio device treatment

EXPERIMENTAL

participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started

Device: Nerivio

Interventions

Nerivio DEVICE

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 ICHD-3 diagnostic criteria for chronic migraine
• 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 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 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 (2)

Health Quest Medical Practice, PC

Lagrangeville, New York, 12540, United States

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Related Publications (1)

• Nierenburg H, Vieira JR, Lev N, Lin T, Harris D, Vizel M, Ironi A, Lewis B, Wright P. Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study. Pain Ther. 2020 Dec;9(2):531-543. doi: 10.1007/s40122-020-00185-1. Epub 2020 Jul 9.

  PMID: 32648205 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

• Paul Wright

  Nuvance Health

  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: November 10, 2019
• First Posted: November 13, 2019
• Study Start: September 18, 2019
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: February 16, 2021
• Results First Posted: January 28, 2021

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IL (1)