Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

Last updated: August 6, 2024
Sponsor: Alberta Health Services, Calgary
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Pain (Pediatric)

Chronic Pain

Treatment

Occipital nerve stimulator implant

Clinical Study ID

NCT04937010
REB21-0839
  • Ages 18-100
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meets ICHD-3 diagnostic criteria for the chronic form of one of the trigeminalautonomic cephalgias (outlined below), as determined by the treating neurologist.

  • Failed standard medical management, meaning at least 3 conventional preventativetherapies.

Exclusion

Exclusion Criteria:

  • Presence of uncontrolled or untreated psychiatric disease

  • Presence of medical contraindications to surgery

  • Patient does not consent to surgery

  • Non-English speaking

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Occipital nerve stimulator implant
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
September 01, 2026

Study 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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N2T9
    Canada

    Active - Recruiting

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