Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

August 6, 2024 updated by: Fady Girgis, Alberta Health Services, Calgary

Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A Double-blind, Phase II, Randomized, Controlled Trial

The objective of this study is to determine the efficacy of occipital nerve stimulation (ONS) in the treatment of chronic trigeminal autonomic cephalalgias (TACs).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N2T9
        • Recruiting
        • University of Calgary
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Industry standard stimulation
Standard sub threshold stimulation parameters
Procedure: Occipital nerve stimulator implant
Implantation of occipital nerve stimulator and different stimulation parameters
Sham Comparator: Experimental stimulation
Sham stimulation
Procedure: Occipital nerve stimulator implant
Implantation of occipital nerve stimulator and different stimulation parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in headache frequency
Time Frame: 6 months
Change in frequency of headaches
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Occipital Nerve Stimulation
Time Frame: 6 months
Any adverse events with stimulation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberta Health Services, Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB21-0839

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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