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Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

Primary Purpose

Episodic Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham Treatment Location
Verum Treatment Location
Sponsored by
Theranova, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Migraine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham

Verum

Arm Description

Treatment at the bicep location

Treatment at the hand location

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2019
Last Updated
July 22, 2021
Sponsor
Theranova, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT04166045
Brief Title
Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
Official Title
Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
April 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theranova, L.L.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Treatment at the bicep location
Arm Title
Verum
Arm Type
Active Comparator
Arm Description
Treatment at the hand location
Intervention Type
Device
Intervention Name(s)
Sham Treatment Location
Intervention Description
The device applies transcutaneous electrical nerve stimulation to the bicep
Intervention Type
Device
Intervention Name(s)
Verum Treatment Location
Intervention Description
The device applies transcutaneous electrical nerve stimulation to the hand
Primary Outcome Measure Information:
Title
Mean change in pain score
Description
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.
Time Frame
4 months
Title
Percent of subjects who are responders
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

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Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

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