Using occipital nerve stimulation to treat chronic headaches
Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A Double-blind, Phase II, Randomized, Controlled Trial
NA · Alberta Health Services, Calgary · NCT04937010
This study is testing if a treatment called occipital nerve stimulation can help people with chronic cluster headaches feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Alberta Health Services, Calgary (other) |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT04937010 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of occipital nerve stimulation (ONS) for patients suffering from chronic trigeminal autonomic cephalalgias (TACs), particularly cluster headaches. It will employ a double-blind, randomized, controlled, cross-over design to minimize bias and placebo effects, allowing for a more accurate assessment of ONS efficacy. Participants will experience both therapeutic and sham stimulation periods, rating their pain and quality of life throughout. After the cross-over phase, all subjects will receive therapeutic stimulation for one year to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with chronic trigeminal autonomic cephalalgias who have not responded to at least three conventional preventative therapies.
Not a fit: Patients with uncontrolled psychiatric conditions, medical contraindications to surgery, or those who do not consent to the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve quality of life for patients with chronic TACs.
How similar studies have performed: Previous open studies and case series have shown some success with occipital nerve stimulation for cluster headaches, but controlled studies in this area are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (RECRUITING)
Study contacts
- Study coordinator: Fady Girgis, MD
- Email: fmgirgis@ucalgary.ca
- Phone: 4039446497
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Trigeminal Autonomic Cephalgia, Occipital Nerve Stimulation