NCT05443659

Brief Summary

This is a Post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, Israel) in adolescents with migraine. Data analysis concerning the REN treatment efficacy in terms of pain and functional disability as a standalone treatment or in combination with other medications will be performed.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,629

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

November 4, 2025

Completed
Last Updated

November 4, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

June 25, 2022

Results QC Date

August 17, 2025

Last Update Submit

October 9, 2025

Conditions

Migraine in Adolescence

Keywords

migraine, Headache Nerivio, REN

Outcome Measures

Primary Outcomes (1)

  • Consistent Pain Relief at 2 Hours Post-treatment

    The proportion of subjects reporting pain relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)

    2 hours post treatment, up to 16 months from the 1st treatment

Secondary Outcomes (4)

  • Consistent Pain Freedom at 2 Hours Post-treatment

    2 hours post treatment, up to 16 months from the 1st treatment

  • Consistent Usage of Migraine Abortive (Rescue) Medications

    2 hours post treatment, up to 16 months from the 1st treatment

  • Consistent Functional Disability Relief at 2 Hours Post-treatment

    2 hours post treatment, up to 16 months from the 1st treatment

  • Consistent Functional Disability Disappearance at 2 Hours Post-treatment

    2 hours post treatment, up to 16 months from the 1st treatment

Other Outcomes (2)

  • Treatment Intensity Distribution

    45 minutes post treatment, up to 16 months from the 1st treatment

  • Device Related Adverse Events

    Up to 16 months

Interventions

NerivioDEVICE

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.

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Adolescence (age 12-18) who suffers from migraine who are using the Nerivio device for acute treatment of migraine

You may qualify if:

  • \- Age between 12-18 years
  • \- REN user across the United States who created Nerivio account on January 1st, 2021 or later.
  • \- Had at least two evaluable treatments with the Nerivio device

You may not qualify if:

  • (1) - Treatments shorter than 20 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Theranica USA Inc

Bridgewater, New Jersey, 08807, United States

Location

Theranica Bio-Electronics Ltd

Netanya, 4250438, Israel

Location

Related Publications (7)

  • Yarnitsky D, Dodick DW, Grosberg BM, Burstein R, Ironi A, Harris D, Lin T, Silberstein SD. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache. 2019 Sep;59(8):1240-1252. doi: 10.1111/head.13551. Epub 2019 May 9.

    PMID: 31074005BACKGROUND

  • Nierenburg H, Rabany L, Lin T, Sharon R, Harris D, Ironi A, Wright P, Chuang L. Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability. Pain Ther. 2021 Dec;10(2):1245-1253. doi: 10.1007/s40122-021-00276-7. Epub 2021 Jun 17.

    PMID: 34138449BACKGROUND

  • 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: 34667919BACKGROUND

  • Hershey AD, Lin T, Gruper Y, Harris D, Ironi A, Berk T, Szperka CL, Berenson F. Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache. 2021 Feb;61(2):310-317. doi: 10.1111/head.14042. Epub 2020 Dec 21.

    PMID: 33349920BACKGROUND

  • Tepper SJ, Lin T, Montal T, Ironi A, Dougherty C. Real-world Experience with Remote Electrical Neuromodulation in the Acute Treatment of Migraine. Pain Med. 2020 Dec 25;21(12):3522-3529. doi: 10.1093/pm/pnaa299.

    PMID: 32935848BACKGROUND

  • Esparham A, Stark-Inbar A, Jekel L, Tamir S, Rabany L, Ironi A, Gautreaux J, Rao R. Acute Treatment of Migraine in Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN). Pediatr Neurol. 2023 May;142:51-55. doi: 10.1016/j.pediatrneurol.2023.02.008. Epub 2023 Feb 21.

    PMID: 36931109BACKGROUND

  • Ailani J, Rabany L, Tamir S, Ironi A, Starling A. Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. Front Pain Res (Lausanne). 2022 Jan 18;2:753736. doi: 10.3389/fpain.2021.753736. eCollection 2021.

    PMID: 35295483RESULT

Related Links

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

1. \- this is not a controlled study. it has a single arm, of Nerivio users 2. \- Efficacy and medication data were voluntarily provided by patients through the app, which contributed to the fact that not all adolescent users provided the required information at the beginning of the treatment and following two hours.

Results Point of Contact

Title
Dr Dagan Harris, VP Clinical and Regulatory Affairs
Organization
Theranica
daganh@theranica.com
+972542220121

Study Officials

  • Alit Stark Inbar, PhD

    Theranica Bio-Electronics ltd

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2022

First Posted

July 5, 2022

Study Start

January 1, 2021

Primary Completion

May 31, 2022

Study Completion

August 24, 2022

Last Updated

November 4, 2025

Results First Posted

November 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)IL(1)