Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Occipital nerve stimulator implant.
- Who it may be relevant to
- Registry conditions: Trigeminal Autonomic Cephalgia. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A Double-blind, Phase II, Randomized, Controlled Trial
Overview
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
- Procedure Occipital nerve stimulator implant
Implantation of occipital nerve stimulator and different stimulation parameters
Primary outcome measures
- Change in headache frequency [Time frame: 6 months]
Secondary outcome measures (1)
- Safety of Occipital Nerve Stimulation [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- University of Calgary — Calgary
Identifiers
NCT: NCT04937010 · REB21-0839