NCT04937010

Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A Double-blind, Phase II, Randomized, Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Alberta Health Services, Calgary · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the efficacy of occipital nerve stimulation (ONS) in the treatment of chronic trigeminal autonomic cephalalgias (TACs).

Detailed description

Several open studies and case series have shown improvement in pain scores using ONS specifically for cluster headache, which is the most common of the TACs. However, neuromodulation in the treatment of pain disorders is subject to strong placebo effect and bias, and the lack of controlled studies in this population makes its true efficacy unknown. Therefore, we plan to study ONS in a population of patients with chronic TACs using a double-blind, randomized, controlled, cross-over study. Using sub-threshold stimulation parameters, meaning patients will not know when therapeutic stimulation is active, subjects will rate their pain and quality of life during both therapeutic and sham stimulation periods. Following the cross-over period, all subjects will undergo therapeutic stimulation for 1-year in order to gauge long-term effects.

Conditions

• Trigeminal Autonomic Cephalgia

Interventions

Type	Name	Description
PROCEDURE	Occipital nerve stimulator implant	Implantation of occipital nerve stimulator and different stimulation parameters

Timeline

• Start date: 2022-02-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-06-23
• Last updated: 2024-08-07

Locations

1 site across 1 country: Canada