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

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ClinicalTrials.gov Identifier: NCT04194008
Recruitment Status : Completed
First Posted : December 11, 2019
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Theranica

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.


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

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of Nerivio, a Remote Electrical Neuromodulation Device, for Acute Treatment of Migraine in People With Chronic Migraine
Actual Study Start Date : November 18, 2019
Actual Primary Completion Date : May 22, 2020
Actual Study Completion Date : August 30, 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
Treatment with active Nerivio device
Device: Nerivio
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.




Primary Outcome Measures :
  1. Pain Relief at 2 Hours Post-treatment [ Time Frame: 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)


Secondary Outcome Measures :
  1. Pain-free at 2 Hours Post-treatment [ Time Frame: 2 hours post-treatment ]
    The proportion of subjects reporting, for the test treatment, no pain at 2 hours post-treatment without the use of rescue medication. Pain-free is defined as improvement from mild, moderate, or severe pain to none. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)

  2. Disappearance of Nausea at 2 Hours Post-treatment [ Time Frame: 2 hours post treatment ]
    The proportion of subjects presented nausea at the migraine onset and reported disappearance of nausea at 2 hours post-treatment of the test treatment

  3. Disappearance of Photophobia at 2 Hours Post-treatment [ Time Frame: 2 hours post treatment ]
    The proportion of subjects presented photohobia at the migraine onset and reported disappearance of photophobia at 2 hours post-treatment of the test treatment

  4. Disappearance of Phonophobia at 2 Hours Post-treatment [ Time Frame: 2 hours post treatment ]
    The proportion of subjects presented phonophobia at the migraine onset and reported disappearance of phonophobia at 2 hours post-treatment of the test treatment


Other Outcome Measures:
  1. Within-subject Consistency of the Pain Relief Response [ Time Frame: throughout the study ]
    proportion of patients achieving pain relief at 2 hours in at least 50% of all their treatments

  2. Functional Disability at 2 Hours Post-treatment [ Time Frame: 2 hours post treatment ]
    The proportion of participants achieving improvement of at least one grade in functional disability in the test treatment at 2 hours post-treatment with no use of rescue medication

  3. Functional Disability at 24 Hours Post-treatment [ Time Frame: 24 hours post treatment ]
    The proportion of participants achieving improvement of at least one grade in functional disability in the test treatment at 24 hours post-treatment with no use of rescue medication

  4. Sustained Pain Relief at 24 Hours Post-treatment [ Time Frame: 24 hours post treatment ]
    The proportion of subjects achieving, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication and no relapse of headache pain within 24 hours



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

Exclusion Criteria:

  1. Participants with an active 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/or 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): NCT04194008


Locations
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United States, California
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States, 92663
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
United States, Connecticut
Hartford Healthcare Center
Hartford, Connecticut, United States, 06102
United States, Mississippi
Headache Neurology Research Institute
Ridgeland, Mississippi, United States, 39157
United States, Missouri
Mercy Hospital
Saint Louis, Missouri, United States, 63141
StudyMetrix Research, LLC
Saint Peters, Missouri, United States, 63303
ClinVest
Springfield, Missouri, United States, 65810
United States, New York
Island Neurological
Plainview, New York, United States, 11803
United States, Pennsylvania
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States, 15220
United States, Tennessee
Nashville neuroscience
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Theranica
Investigators
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Principal Investigator: Brian Grosberg, MD Hartford Healthcare Center
  Study Documents (Full-Text)

Documents provided by Theranica:
Informed Consent Form  [PDF] September 1, 2019

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Responsible Party: Theranica
ClinicalTrials.gov Identifier: NCT04194008    
Other Study ID Numbers: TCH006
First Posted: December 11, 2019    Key Record Dates
Results First Posted: February 2, 2021
Last Update Posted: February 2, 2021
Last Verified: September 2020
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