NCT04937010

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Feb 2022Sep 2026

First Submitted

Initial submission to the registry

June 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

4.6 years

First QC Date

June 16, 2021

Last Update Submit

August 6, 2024

Conditions

Trigeminal Autonomic Cephalgia

Keywords

Occipital Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in headache frequency

    Change in frequency of headaches

    6 months

Secondary Outcomes (1)

  • Safety of Occipital Nerve Stimulation

    6 months

Study Arms (2)

Industry standard stimulation

ACTIVE COMPARATOR

Standard sub threshold stimulation parameters

Procedure: Occipital nerve stimulator implant

Experimental stimulation

SHAM COMPARATOR

Sham stimulation

Procedure: Occipital nerve stimulator implant

Interventions

Occipital nerve stimulator implantPROCEDURE

Implantation of occipital nerve stimulator and different stimulation parameters

Experimental stimulationIndustry standard stimulation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of uncontrolled or untreated psychiatric disease
  • Presence of medical contraindications to surgery
  • Patient does not consent to surgery
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N2T9, Canada

RECRUITING

MeSH Terms

Conditions

Trigeminal Autonomic Cephalalgias

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Fady Girgis, MD

CONTACT

4039446497fmgirgis@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 23, 2021

Study Start

February 1, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)