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ACTIVE NOT RECRUITING
NCT07451158
NA

Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal TENS Device for Migraine Treatment

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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