NCT05301920

The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine

A Single-center, Open-label, Clinical Effect Observational Study to Evaluate the Safety and Effectiveness of Reducing the Frequency of Migraine Onset Through Clinical Application of Elexir (Trigeminal Nerve Electrical Stimulator) in Migraine Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Nu Eyne Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and effectiveness of trigeminal nerve electrical stimulator on reducing the frequency of migraine onset. It is applied to migraine patients and analyzes the results by comparing them before and after 4weeks.

Detailed description

* Duration of study period (per participant): Screening period (-6\~0weeks), Intervention period (4weeks). * Patient needs to visit site at least 3 times (Screening, Baseline, V4), V2 can be done with screening visit. V3 is tele-Visit. * The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time. * During the study period, examination and treatment methods are carried out in the same way.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Elexir (trigeminal nerve electrical stimulator)	Elexir performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.

Timeline

• Start date: 2021-10-08
• Primary completion: 2022-01-28
• Completion: 2022-01-28
• First posted: 2022-03-31
• Last updated: 2023-12-14

Locations

1 site across 1 country: South Korea