Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias
Primary Purpose
Trigeminal Autonomic Cephalgia
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Occipital nerve stimulator implant
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Autonomic Cephalgia focused on measuring Occipital Nerve Stimulation
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
Sites / Locations
- University of CalgaryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Industry standard stimulation
Experimental stimulation
Arm Description
Standard sub threshold stimulation parameters
Sham stimulation
Outcomes
Primary Outcome Measures
Change in headache frequency
Change in frequency of headaches
Secondary Outcome Measures
Safety of Occipital Nerve Stimulation
Any adverse events with stimulation
Full Information
NCT ID
NCT04937010
First Posted
June 16, 2021
Last Updated
July 19, 2023
Sponsor
Alberta Health Services, Calgary
1. Study Identification
Unique Protocol Identification Number
NCT04937010
Brief Title
Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias
Official Title
Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A Double-blind, Phase II, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alberta Health Services, Calgary
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Autonomic Cephalgia
Keywords
Occipital Nerve Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Industry standard stimulation
Arm Type
Active Comparator
Arm Description
Standard sub threshold stimulation parameters
Arm Title
Experimental stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation
Intervention Type
Procedure
Intervention Name(s)
Occipital nerve stimulator implant
Intervention Description
Implantation of occipital nerve stimulator and different stimulation parameters
Primary Outcome Measure Information:
Title
Change in headache frequency
Description
Change in frequency of headaches
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety of Occipital Nerve Stimulation
Description
Any adverse events with stimulation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fady Girgis, MD
Phone
4039446497
Email
fmgirgis@ucalgary.ca
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fady Girgis, MD
Phone
4039446497
Email
fmgirgis@ucalgary.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias
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