What side effects are associated with this type of intervention?

Common treatments for cluster headaches include occipital nerve stimulation (ONS), which involves electrical impulses to modulate pain pathways. Known side effects of ONS can include mild to moderate discomfort at the stimulation site, such as tingling, numbness, or muscle spasms. There are generally no serious adverse events reported with this treatment. Other treatments like transcutaneous supraorbital nerve stimulation and transcranial magnetic stimulation (TMS) also involve electrical or magnetic impulses and can cause side effects such as lightheadedness, tingling, and mild discomfort at the application site.

What prior FDA approvals exist?

The FDA has approved several treatments for cluster headache, including high cervical spinal cord stimulation and occipital nerve stimulation (ONS). These treatments involve the use of electrical impulses to modulate pain pathways, providing relief for patients with intractable cluster headaches. Additionally, other pharmacological treatments such as verapamil and lithium have been used, although they do not involve neuromodulation.

What other types of research exist?

Promising, novel alternatives to Occipital Nerve Stimulation for Cluster Headache patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown significant pain reduction in clinical trials. 2) Remote electrical neuromodulation (REN), which uses a device controlled by a smartphone to provide nonpainful electrical skin stimulation and has demonstrated efficacy in reducing migraine pain. 3) Noninvasive vagus nerve stimulation (nVNS), which has been effective in acute migraine therapy and may offer benefits for cluster headache patients as well.

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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

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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

0 / 3Eligibility criteria met

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.