Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

NCT04166045 | Completed

• 1 other identifier: CRD-01-1282-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Episodic Migraine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sham

SHAM COMPARATOR

Treatment at the bicep location

Device: Sham Treatment Location

Verum

ACTIVE COMPARATOR

Treatment at the hand location

Device: Verum Treatment Location

Interventions

Sham Treatment Location DEVICE

The device applies transcutaneous electrical nerve stimulation to the bicep

Sham

Verum Treatment Location DEVICE

The device applies transcutaneous electrical nerve stimulation to the hand

Verum

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years, inclusive
• Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theranova, L.L.C.: lead

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 18, 2019
• Study Start: June 12, 2020
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

US (1)