Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

Episodic Migraine Clinical Trial

Official title:

Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04166045
• Other study ID #: CRD-01-1282-01
• Status: Completed
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: April 29, 2021

Study information

• Verified date: July 2021
• Source: Theranova, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Device:
• Sham Treatment Location
The device applies transcutaneous electrical nerve stimulation to the bicep
• Verum Treatment Location
The device applies transcutaneous electrical nerve stimulation to the hand

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Theranova, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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