Occipital Nerve Stimulation for Chronic Migraines

Overseen By Fady Girgis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alberta Health Services, Calgary

Disqualifiers: Uncontrolled psychiatric disease, Surgery contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Occipital nerve stimulator implant for chronic migraines?

Occipital nerve stimulation (ONS) is being explored as a promising treatment for chronic migraines, with some studies showing potential benefits. However, results are mixed, and more research is needed to confirm its effectiveness and improve safety. ^{1 2 3 4 5}

Is occipital nerve stimulation safe for treating chronic migraines?

Occipital nerve stimulation for chronic migraines has shown some safety concerns, including high rates of lead migration (movement of the device), infections, and persistent pain related to the stimulator. While preliminary studies suggest it can be safe, these complications highlight the need for improved surgical techniques and further research to ensure long-term safety. ^{2 3 6 7 8}

How does occipital nerve stimulation differ from other treatments for chronic migraines?

Occipital nerve stimulation (ONS) is a unique treatment for chronic migraines that involves implanting a device to stimulate the occipital nerves at the back of the head, which is different from typical medication-based treatments. While it shows promise, its effectiveness is still under investigation, and it may be more beneficial when combined with stimulation of other nerves, like the supraorbital nerves. ^{1 2 3 5 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have tried at least 3 standard treatments without success.

You have been diagnosed with a specific type of chronic headache by a neurologist.

Exclusion Criteria

I cannot undergo surgery due to health risks.

Patient does not consent to surgery

You have a mental health condition that is not being managed or treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a double-blind, randomized, controlled, cross-over study with both therapeutic and sham stimulation periods

6 months

Long-term therapeutic stimulation

All subjects receive therapeutic stimulation to gauge long-term effects

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Occipital nerve stimulator implant

Trial Overview 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.

Participant Groups

Group I: Industry standard stimulation Active Control 1 Intervention

Standard sub threshold stimulation parameters

Group II: Experimental stimulation Placebo Group 1 Intervention

Sham stimulation

Who Is Running the Clinical Trial?

Alberta Health Services, Calgary

Lead Sponsor

Trials

15

Recruited

2,600+

Findings from Research

Occipital nerve stimulation shows potential effectiveness in treating chronic migraines, with five out of six studies indicating some benefit, including three double-blind studies.

Despite the promising results, none of the three randomized controlled trials achieved their primary endpoints, suggesting that further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occipital nerve stimulation for chronic migraine. Young, WB.[2021]

Occipital nerve stimulation (ONS) has shown promising results as a preventive treatment for refractory chronic migraine, with over 50% pain reduction reported in many studies, indicating its efficacy.

ONS is considered safe and well-tolerated, with most side effects being local and manageable, such as electrode displacement or surgical site infections, which typically do not necessitate removal of the electrodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Occipital nerve stimulation for refractory chronic migraine]. Bermejo, PE., Torres, CV., Sola, RG.[2018]

Occipital nerve stimulation (ONS) is being studied for treating chronic migraines, but current evidence from clinical trials is inconclusive about its effectiveness.

There are significant safety concerns with ONS, including high rates of lead migration, infection, and persistent pain, indicating a need for improved implantation techniques and further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occipital Nerve Stimulation for Migraine: Update from Recent Multicenter Trials. Schwedt, TJ., Green, AL., Dodick, DW.[2015]

Occipital nerve stimulation (ONS) is being explored as a potential treatment for patients with chronic daily headaches who do not respond to traditional therapies, addressing a significant unmet medical need.

ONS works by electrically stimulating the occipital nerve, which can influence pain perception in both the peripheral and central nervous systems, suggesting it may effectively modulate headache pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occipital nerve stimulation for medically intractable headache. Schwedt, TJ.[2021]

Occipital nerve stimulation (ONS) has been shown to reduce the number of days with moderate to severe headaches by an average of 2.59 days per month compared to sham controls, based on pooled data from five randomized controlled trials involving 402 participants.

While ONS demonstrates some effectiveness for chronic migraine, the average effect size is modest, and there are significant risks of adverse events such as lead migration and infections, which may require additional surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occipital nerve stimulation for chronic migraine--a systematic review and meta-analysis. Chen, YF., Bramley, G., Unwin, G., et al.[2023]

In a study involving 157 patients over 52 weeks, peripheral nerve stimulation (PNS) of the occipital nerves significantly reduced headache days by an average of 6.7 days, with 59.5% of patients experiencing at least a 30% reduction in headache frequency.

While PNS showed promising efficacy in managing chronic migraines, it was associated with a high rate of adverse events, with 70% of patients experiencing complications, highlighting the need for improved safety measures in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: long-term results from a randomized, multicenter, double-blinded, controlled study. Dodick, DW., Silberstein, SD., Reed, KL., et al.[2022]

Implanting the pulse generator (IPG) closer to the lead location, such as in the infraclavicular region, significantly reduces the incidence of adverse events (AEs) related to peripheral nerve stimulation (PNS) for chronic migraine management, indicating a safer surgical approach.

Increased experience of the implanter, measured by the number of prior PNS implants performed, is associated with a lower rate of stimulation- and hardware-related AEs, suggesting that skill and precision improve with practice, leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Sharan, A., Huh, B., Narouze, S., et al.[2022]

Occipital nerve stimulation shows promise as a treatment for chronic migraines, with preliminary studies indicating it can improve quality of life and reduce medication use, although these studies are still in early stages.

Despite its potential benefits, the procedure carries significant risks, including high rates of complications such as lead migration and surgical site infections, highlighting the need for improved techniques and further research on long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of implantable neurostimulation devices in the treatment of chronic migraine. Freeman, JA., Trentman, TL.[2021]

In a study involving seven patients with chronic migraines unresponsive to other treatments, combined neurostimulation of both occipital and supraorbital nerves resulted in a full therapeutic response for all participants over a follow-up period of 1 to 35 months.

The results indicated that combined stimulation was significantly more effective than occipital nerve stimulation alone, suggesting that targeting both nerve pathways may enhance treatment outcomes for chronic migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience. Reed, KL., Black, SB., Banta, CJ., et al.[2010]

References

1. United States pubmed.ncbi.nlm.nih.gov

Occipital nerve stimulation for chronic migraine. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

[Occipital nerve stimulation for refractory chronic migraine]. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Occipital Nerve Stimulation for Migraine: Update from Recent Multicenter Trials. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Occipital nerve stimulation for medically intractable headache. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Occipital nerve stimulation for chronic migraine--a systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: long-term results from a randomized, multicenter, double-blinded, controlled study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical utility of implantable neurostimulation devices in the treatment of chronic migraine. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience. [2010]