Migraine Prevention Using ActiPatch

Completed · Not applicable · Has a placebo group

Conditions studied: Migraine

In brief

Chronic pain is now widely understood to be due to central sensitization, which leads to exaggerated pain perception. Migraine is no exception, since it is well known that sensitization of the trigeminovascular pain pathway can occur during a migraine attach. There is early evidence that ActiPatch can help mitigate this sensitization, so this study is being conducted to determine the efficacy of ActiPatch in preventing chronic, episodic migraines.

Key facts

Study ID

NCT03166046

Run by

BioElectronics Corporation

People needed

45

Starts

2017-06-01

Expected to finish

2018-04-30

Last updated by the study team

2018-08-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is willing and able to give informed consent for participation in the trial.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.
• Male or female ages 18 or above with migraine headache
• 3 or greater occurrences of migraine per month
• no prior use of neuromodulation for migraine headache

You may not qualify if…

• Female participant who is pregnant
• prior use of neuromodulation for migraine headache
• Laminectomy, laminotomy or discectomy within 12 months of enrollment.
• Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia).
• Patients diagnosed with history of significant mood disorder will be excluded (e.g., depression or anxiety with adequate control would be acceptable).
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Where it is running

• Eppley Group — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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