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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04937010

Enrollment

Registered

2021-06-23

Start date

2022-02-01

Completion date

2026-09-01

Last updated

2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Autonomic Cephalgia

Keywords

Occipital Nerve Stimulation

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.

Interventions

PROCEDUREOccipital nerve stimulator implant

Implantation of occipital nerve stimulator and different stimulation parameters

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in headache frequency	6 months	Change in frequency of headaches

Secondary

Measure	Time frame	Description
Safety of Occipital Nerve Stimulation	6 months	Any adverse events with stimulation

Countries

Canada

Contacts

Primary ContactFady Girgis, MD

fmgirgis@ucalgary.ca4039446497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026