Evaluation of Peripheral Nerve Stimulat… | Clinical Trial

Key information

Conditions

Episodic Migraine

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham Treatment Location

Device

The device applies transcutaneous electrical nerve stimulation to the bicep

Verum Treatment Location

Device

The device applies transcutaneous electrical nerve stimulation to the hand

Primary outcomes

Mean change in pain score

Time frame: 4 months

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.
Percent of subjects who are responders

Time frame: 4 months

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.

Sponsors and collaborators

Lead sponsor

Theranova, L.L.C.

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Nov 18, 2019
Registry last updated: Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed