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Neurostimulation
Occipital Nerve Stimulation for Chronic Migraines
N/A
Recruiting
Research Sponsored by Alberta Health Services, Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failed standard medical management, meaning at least 3 conventional preventative therapies.
Be older than 18 years old
Must not have
Non-English speaking
Presence of medical contraindications to surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial aims to test if occipital nerve stimulation (ONS) can effectively reduce pain in patients with chronic trigeminal autonomic cephalalgias (TACs), especially cluster headaches. The treatment works by sending electrical impulses to the nerves at the back of the head to block pain signals. The study will compare different treatment periods to see if patients feel better with the actual treatment. Occipital nerve stimulation (ONS) has been studied for various chronic headache disorders, including chronic migraine and cluster headaches, with some evidence supporting its efficacy.
Who is the study for?
This trial is for people with chronic trigeminal autonomic cephalalgias (TACs), including cluster headaches, who haven't found relief from at least three standard treatments. Participants must meet specific diagnostic criteria and agree to surgery. Those with untreated psychiatric conditions, medical reasons preventing surgery, or who don't speak English can't join.
What is being tested?
The study is testing the effectiveness of an occipital nerve stimulator implant in treating TACs. This device is surgically placed under the skin near the occipital nerves at the base of the skull to help alleviate headache symptoms.
What are the potential side effects?
Potential side effects may include pain or discomfort at the implant site, infection risk from surgery, possible nerve damage leading to muscle weakness or sensory changes, and device-related complications such as malfunction or battery issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least 3 standard treatments without success.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English.
Select...
I cannot undergo surgery due to health risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in headache frequency
Secondary study objectives
Safety of Occipital Nerve Stimulation
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Industry standard stimulationActive Control1 Intervention
Standard sub threshold stimulation parameters
Group II: Experimental stimulationPlacebo Group1 Intervention
Sham stimulation
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cluster headaches are severe, unilateral headaches often accompanied by autonomic symptoms. Treatments aim to modulate pain pathways and reduce headache frequency and intensity.
Occipital nerve stimulation (ONS) involves electrical impulses to the occipital nerves, which can alter pain signaling pathways and reduce headache frequency. This is significant for patients as it offers a non-pharmacological option, potentially reducing medication side effects and providing relief when other treatments fail.
Understanding these mechanisms helps tailor treatments to individual patient needs, improving outcomes.
High cervical spinal cord stimulation for chronic cluster headache.
High cervical spinal cord stimulation for chronic cluster headache.
Find a Location
Who is running the clinical trial?
Alberta Health Services, CalgaryLead Sponsor
13 Previous Clinical Trials
2,544 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo surgery due to health risks.I have tried at least 3 standard treatments without success.You have been diagnosed with a specific type of chronic headache by a neurologist.I do not speak English.You have a mental health condition that is not being managed or treated.
Research Study Groups:
This trial has the following groups:- Group 1: Industry standard stimulation
- Group 2: Experimental stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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