Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

  • STATUS
    Recruiting
  • End date
    Sep 1, 2026
  • participants needed
    20
  • sponsor
    Alberta Health Services, Calgary
Updated on 13 March 2022

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.

Details
Condition Trigeminal Autonomic Cephalgia
Treatment Occipital nerve stimulator implant
Clinical Study IdentifierNCT04937010
SponsorAlberta Health Services, Calgary
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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