An interventional study of Occipital nerve stimulator implant in Trigeminal Autonomic Cephalgia, sponsored by Alberta Health Services, Calgary. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Alberta Health Services, Calgary · Not applicable, Interventional, and Treatment
The objective of this study is to determine the efficacy of occipital nerve stimulation (ONS) in the treatment of chronic trigeminal autonomic cephalalgias (TACs).
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.
Alberta Health Services, Calgary is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard sub threshold stimulation parameters
Procedure: Occipital nerve stimulator implant
Sham stimulation
Procedure: Occipital nerve stimulator implant
Implantation of occipital nerve stimulator and different stimulation parameters
Change in headache frequency
Change in frequency of headaches
Time frame: 6 months
Safety of Occipital Nerve Stimulation
Any adverse events with stimulation
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Sep 2026, 55 months after the start.
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Trigeminal Autonomic Cephalalgias
Alberta Health Services, Calgary