NCT05804396

Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine

The SP-303 PERL Study - Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Neurolief Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PERL Study will evaluate the safety and efficacy of a self-administered preventive treatment for migraine headache using combined occipital and trigeminal nerve stimulation (Relivion®). This is a prospective, non-randomized, single arm, multi-center study designed to evaluate the use of Relivion® in reducing the frequency of headache days against a sham performance goal.

Detailed description

The study will include the following study visits \& phases: * Visit 1 Screening * Run-in (Baseline) Period - Daily migraine headache diary. * Visit 2 Enrollment -Study enrollment, device and regimen training. * Treatment Period- Relivion® migraine preventive treatment for 12 consecutive weeks. Patients will be required to fill in a daily migraine diary. * Visit 3 Follow Up Visit. * Visit 4 Follow Up Visit. * Visit 5 End of study. After completion of visit 5 the subject's participation will be over.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Relivion®	Active stimulation device

Timeline

• Start date: 2024-11-24
• Primary completion: 2024-11-24
• Completion: 2024-11-24
• First posted: 2023-04-07
• Last updated: 2024-12-02

Regulatory

• FDA-regulated device study