Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

Not Applicable

Recruiting

• Conditions: Trigeminal Autonomic Cephalgia
• Interventions: Procedure: Occipital nerve stimulator implant

• Registration Number: NCT04937010
• Lead Sponsor: Alberta Health Services, Calgary

Brief 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.

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-23
• Study Start: 2022-02-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Meets ICHD-3 diagnostic criteria for the chronic form of one of the trigeminal autonomic cephalgias (outlined below), as determined by the treating neurologist.
• Failed standard medical management, meaning at least 3 conventional preventative therapies.

Exclusion Criteria

• Presence of uncontrolled or untreated psychiatric disease
• Presence of medical contraindications to surgery
• Patient does not consent to surgery
• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental stimulation	Occipital nerve stimulator implant	Sham stimulation
Industry standard stimulation	Occipital nerve stimulator implant	Standard sub threshold stimulation parameters

Primary Outcome Measures

Name	Time	Method
Change in headache frequency	6 months	Change in frequency of headaches

Secondary Outcome Measures

Name	Time	Method
Safety of Occipital Nerve Stimulation	6 months	Any adverse events with stimulation

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada