Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

Trigeminal Autonomic Cephalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937010
• Other study ID #: REB21-0839
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: July 2023
• Source: Alberta Health Services, Calgary
• Contact: Fady Girgis, MD
• Phone: 4039446497
• Email: fmgirgis[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Trigeminal Autonomic Cephalgia

Intervention

Procedure:
• Occipital nerve stimulator implant
Implantation of occipital nerve stimulator and different stimulation parameters

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Health Services, Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in headache frequency	Change in frequency of headaches	6 months
Secondary	Safety of Occipital Nerve Stimulation	Any adverse events with stimulation	6 months