40
Participants
Start Date
October 3, 2022
Primary Completion Date
November 30, 2024
Study Completion Date
November 30, 2024
Active Cefaly Dual (R)
Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A biphasic rectangular wave will be delivered for a maximum of 20 minutes at a maximum amplitude of 16mA. Participant may halt amplitude before it reaches maximum amplitude. The device has previously been cleared by the FDA for use in migraine patients.
Sham Cefaly Dual (R)
Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A 1Hz wave will be delivered for 20 minutes at 1mA.
Miami VA Healthcare System, Miami, FL, Miami
VA Office of Research and Development
FED