Evaluation of a Novel Device for Treatment of Migraine Headache

NCT03361423 | Completed Results DMC FDA Device

• 1 other identifier: TCH003
• Study Type: interventional
• Target: 296
• Locations: 2 countries
• Sites: 12

Brief Summary

Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. It is tolerable by patients and associated with no adverse effects. The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere. This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications. The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra electro stimulation device for the reduction of migraine headache during an attack of migraine with or without aura. The study is intended for subject with 2-8 migraine episodes per month. patients will receive the device, either an active or a placebo type, and will be asked to use the device at home or in any location that they will be when the migraine starts. The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral nervous system at onset of a migraine attack significantly reduce headache pain demonstrated by a significant difference between proportions of responders to the active treatment stimulation in comparison to proportion of responders that will use a placebo device.

Conditions

Migraine Without Aura; Migraine With Aura

Outcome Measures

Primary Outcomes (1)

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

  The percentage of patients reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their first treated migraine attack (excluding the "run-in test" treatment).

  2 hours post migraine onset

Secondary Outcomes (3)

• Percentage of Participants With Reduction of Most Bothersome Migraine-associated Symptom (MBS) Relief at 2 Hours Post Treatment

  2 hours post migraine onset

• Percentage of Participants With Reduced Migraine Headache AND MBS Relief at 2 Hours Post Treatment

  2 hours post migraine onset

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

  2 hours post migraine onset

Other Outcomes (4)

• Number of Adverse Events Related or Unrelated to the Study Device

  up to 14 weeks

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

  up to 6 weeks

• Percentage of Participants With Sustained Pain-free 48 Hours With Single Use of the Device

  48 hours post treatment

Study Arms (2)

treatment of migraine with active device

ACTIVE COMPARATOR

Treatment of acute migraine with an active form of Nerivio migra-1 device

Device: Nerivio Migra-1 active device

treatment of migraine with sham device

SHAM COMPARATOR

Treatment of acute migraine with a sham form of the Nerivio Migra-1 device

Device: Nerivio Migra-1 Sham device

Interventions

Nerivio Migra-1 active device DEVICE

The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.

treatment of migraine with active device

Nerivio Migra-1 Sham device DEVICE

The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.

treatment of migraine with sham device

Eligibility Criteria

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

You may qualify if:

• Subjects age 18-75 years old.
• Subjects meet the ICHD-3 diagnostic criteria for migraine with or without aura
• Subjects report 2-8 migraine attacks per month.
• Stable migraine preventive medications in the last two months prior to recruitment (No change in usage or dosage).
• Subjects must be able and willing to comply with the protocol
• Subjects must be able and willing to provide written informed consent

You may not qualify if:

• Subject has other significant pain, medical or psychologic problems that in the opinion of the investigator may confound the study assessments
• Subject has an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
• Subject has known uncontrolled epilepsy.
• Any use of Cannabis including medical use.
• Subject has \>10 headache days per month.
• Subject has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
• Subject is participating in any other clinical study.
• The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
• Pregnant, or trying to get pregnant
• Subject is experiencing a menstrually related migraine
• Received OnabotulinumtoxinA or any botulinum toxin injections for migraine within the previous month
• Received parenteral infusions for migraine within the previous 2 weeks.
• Subject participated in a previous study with the Nerivio Migra 1 device

Sponsors & Collaborators

• Theranica: lead
• Rambam Health Care Campus: collaborator
• Northwell Health: collaborator

Study Sites (12)

Hartford Headache Center

Hartford, Connecticut, 06107, United States

Location

Clinvest Research

Springfield, Missouri, 65810, United States

Location

Mercy Hospital

St Louis, Missouri, 63141, United States

Location

Clinical Reseach Consortium

Las Vegas, Nevada, 89119, United States

Location

Northwell Health, Inc

New York, New York, 11042, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Rambam Medical Center

Haifa, Israel

Location

wolfson Medical Center

Holon, 58100, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Belinson Medical Center

Petah Tikva, 4941492, Israel

Location

Souraskyr Medical center - Ichilov

Tel Aviv, Israel

Location

Related Publications (2)

• Rapoport AM, Bonner JH, Lin T, Harris D, Gruper Y, Ironi A, Cowan RP. Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications. J Headache Pain. 2019 Jul 22;20(1):83. doi: 10.1186/s10194-019-1033-9.

  PMID: 31331265 DERIVED

• 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: 31074005 DERIVED

MeSH Terms

Conditions

Migraine without Aura; Migraine with Aura

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

No limitations or caveats to report

Results Point of Contact

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

daganh@theranica.com

+972723909755

Study Officials

• David Yarnitsky, Prof

  Rambam Medical Center, Israel

  STUDY DIRECTOR

• Moris Levin, MD

  University California Sun Francisco, USA

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: For sham control, electrical pulses of similar width and intensity, but much lower frequency compared to the active device will be administered. This sham program produces pulses that are perceivable by the user, thus maintaining the blinding, but on the other hand do not have therapeutic qualities. The devices will be delivered with an identifying number, without exposing to the investigator or participant if it is an active or a pacebo/sham device
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, double blinded, sham controlled study

Study Record Dates

• First Submitted: November 18, 2017
• First Posted: December 4, 2017
• Study Start: December 17, 2017
• Primary Completion: November 25, 2018
• Study Completion: December 25, 2018
• Last Updated: May 19, 2021
• Results First Posted: May 19, 2021

Record last verified: 2019-02

Locations

US (7); IL (5)