NCT07451158

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

Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine Treatment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment.

Conditions

• Migraine

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-11-15
• Primary completion: 2026-10-30
• Completion: 2026-10-30
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: China