Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.

Study Overview

• Status: Completed
• Conditions: Episodic Migraine
• Intervention / Treatment: Device: Sham Treatment Location; Device: Verum Treatment Location

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-100 years, inclusive
• Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
• 4-14 migraine days per month
• Ability to provide informed consent
• Demonstrates no contraindication to the use of electrical nerve stimulation
• Capable and willing to follow all study-related procedures

Exclusion Criteria:

• Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period
• Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria
• Any medical condition that would, in the opinion of the investigator, make the subject ineligible
• Has received botulinum toxin injections within the past 3 months
• Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant
• Use of investigational drug/device therapy within the past 4 weeks
• Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy)
• No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Sham; Treatment at the bicep location	Device: Sham Treatment Location; The device applies transcutaneous electrical nerve stimulation to the bicep
ACTIVE_COMPARATOR: Verum; Treatment at the hand location	Device: Verum Treatment Location; The device applies transcutaneous electrical nerve stimulation to the hand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in pain score	We will also assess the change in migraine pain before versus after treatment with the 100-mm Visual Analogue Scale (VAS), which is a continuum scale that patients can quantify their pain from none (0 mm) to extreme (100 mm) for both treatment sites. The mean score for each patient cohort will be calculated. We will also perform a sub analysis on women versus men.	4 months
Percent of subjects who are responders	For each subject treatment effectiveness will be assessed by both achieving pain relief (if the pain decreases from a 4-point visual rating scale (VRS) of 'severe' or 'moderate' at pre-treatment to 'mild' or 'none' at 120-min post-treatment) or pain-free ('none') status. The percent of subjects that experience a significant reduction in pain relief score (VRS) will be calculated for the verum and sham treatment sites.	4 months

Collaborators and Investigators

• Sponsor: Theranova, L.L.C.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2020
• Primary Completion (ACTUAL): April 29, 2021
• Study Completion (ACTUAL): April 29, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (ACTUAL): November 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: CRD-01-1282-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No