Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain

TheraNova

Status: Completed

Conditions: Episodic Migraine

Treatments: Device: Sham Treatment Location; Device: Verum Treatment Location

Study type: Interventional

Funder types: Industry

Identifiers

NCT04166045

CRD-01-1282-01

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Sham

Sham Comparator group

Description:

Treatment at the bicep location

Treatment:

Device: Sham Treatment Location

Verum

Active Comparator group

Description:

Treatment at the hand location

Treatment:

Device: Verum Treatment Location