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Trial record 1 of 1 for:    NCT04161807
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Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine

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ClinicalTrials.gov Identifier: NCT04161807
Recruitment Status : Completed
First Posted : November 13, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Theranica

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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Device: Nerivio Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nerivio™, a Remote Electrical Neuromodulation Device, for Acute Treatment of Migraine in People With Chronic Migraine: an Open Label, Single Arm, Multicenter Study
Actual Study Start Date : September 18, 2019
Actual Primary Completion Date : February 18, 2020
Actual Study Completion Date : February 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Nerivio device treatment
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
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.




Primary Outcome Measures :
  1. Pain relief at 2 hours post-treatment [ Time Frame: 2 hours post-treatment ]
    The proportion of participants 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants aged 18-75 years old.
  2. Participants meeting the ICHD-3 diagnostic criteria for chronic migraine
  3. Participants have personal access to a smartphone
  4. Participants must be able and willing to comply with the protocol
  5. Participants must be able and willing to provide written informed consent

Exclusion Criteria:

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

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): NCT04161807


Locations
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United States, New York
Health Quest Medical Practice, PC
Lagrangeville, New York, United States, 12540
Israel
Meir Medical Center
Kfar Saba, Israel, 4428164
Sponsors and Collaborators
Theranica
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Theranica
ClinicalTrials.gov Identifier: NCT04161807    
Other Study ID Numbers: TCH005
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases