Recruiting

Occipital Nerve Stimulation

Sponsor:

Alberta Health Services, Calgary

Code:

NCT04937010

Conditions

Trigeminal Autonomic Cephalgia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Occipital nerve stimulator implant

Study Details

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).

Conditions

Trigeminal Autonomic Cephalgia

Study ID

NCT04937010

Start date

Feb 1, 2022

Status verified date

Aug, 2024

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Industry standard stimulation

Standard sub threshold stimulation parameters

sham comparator: Experimental stimulation

Sham stimulation

Interventions

Occipital nerve stimulator implant

Implantation of occipital nerve stimulator and different stimulation parameters

Primary outcome measure

  • Change in headache frequency [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Fady Girgis, MD

4039446497fmgirgis@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N2T9

Contacts

Fady Girgis, MD

4039446497fmgirgis@ucalgary.ca

More Information

Sponsor

Alberta Health Services, Calgary

Last update posted

Aug 7, 2024

Last verified

Aug, 2024

Keywords

  • Occipital Nerve Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alberta Health Services, Calgary on 2024-08-07.