Trigeminal Autonomic CephalgiaNCT04937010
Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias
A study testing Occipital nerve stimulator implant in people with Trigeminal Autonomic Cephalgia, run by Alberta Health Services, Calgary at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Trigeminal Autonomic Cephalgia
- What is being tested?
- Occipital nerve stimulator implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of uncontrolled or untreated psychiatric disease
- Presence of medical contraindications to surgery
- Patient does not consent to surgery
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N2T9
Fady Girgis, MD, 4039446497, fmgirgis@ucalgary.ca
About this study
Official title: 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).
Read the 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.
- Conditions
- Trigeminal Autonomic Cephalgia
- Being tested
- Occipital nerve stimulator implant
- Keywords
- Occipital Nerve Stimulation
- Medical subject headings
- Trigeminal Autonomic Cephalalgias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital nerve stimulator implantProcedure or surgery
Implantation of occipital nerve stimulator and different stimulation parameters
| Study group | Role | What they receive |
|---|---|---|
| Industry standard stimulation | Active comparator | Standard sub threshold stimulation parameters Receives: Procedure: Occipital nerve stimulator implant |
| Experimental stimulation | Sham comparator | Sham stimulation Receives: Procedure: Occipital nerve stimulator implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headache frequency
Change in frequency of headaches
Measured: 6 months
Secondary outcomes (1)
Safety of Occipital Nerve Stimulation
Any adverse events with stimulation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Feb 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal Autonomic CephalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health Services, Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady Girgis, Alberta Health Services, Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937010
- Sponsor's protocol ID
- REB21-0839
- Status last verified
- Aug 2024
- First submitted
- 16 Jun 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A Double-blind, Phase II, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04937010
- Acronym / sponsor ID
- REB21-0839
- Conditions
- Trigeminal Autonomic Cephalgia
- Keywords
- Occipital Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alberta Health Services, CalgaryUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Industry standard stimulation | Active comparator | Procedure: Occipital nerve stimulator implantStandard sub threshold stimulation parameters |
| Experimental stimulation | Sham comparator | Procedure: Occipital nerve stimulator implantSham stimulation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Presence of uncontrolled or untreated psychiatric disease
- Presence of medical contraindications to surgery
- Patient does not consent to surgery
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occipital nerve stimulator implantImplantation of occipital nerve stimulator and different stimulation parameters | Procedure or surgery | Experimental stimulation, Industry standard stimulation |
Primary outcome
Change in headache frequency
Time frame: 6 months
Change in frequency of headaches
1 secondary outcome
Safety of Occipital Nerve Stimulation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occipital nerve stimulator implant in people with Trigeminal Autonomic Cephalgia, run by Alberta Health Services, Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fady Girgis, MD (4039446497, fmgirgis@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in headache frequency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.