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Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal TENS Device for Migraine Treatment
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment.
Official title: Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine Treatment
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
206
Start Date
2025-11-15
Completion Date
2026-10-30
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation
When subjects report experiencing or impending headache episodes, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) therapy in the treatment area. Prior to activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Subsequently, activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. A safety follow-up (telephone consultation or online questionnaire) should be completed one week after the treatment session.
Fake Stimulus
When subjects experience or anticipate headache onset, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) in a non-treatment area. Before activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Then activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. Complete a safety follow-up one week after the same-day treatment (via telephone consultation or online questionnaire).
Locations (1)
Electrical stimulator
Hangzhou, Zhejiang, China