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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of an occipital nerve stimulator for individuals with chronic trigeminal autonomic cephalalgias (TACs), a type of severe headache. The treatment involves implanting a device that manages pain by sending electrical signals to nerves in the back of the head. Participants will receive either the standard stimulation or a sham stimulation. Ideal candidates are those diagnosed with chronic TACs who have not found relief with at least three typical preventive treatments. As an unphased trial, this study offers patients the chance to explore a novel treatment option that might provide relief where other treatments have failed.

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 prior data suggests that the occipital nerve stimulator implant is safe for treating chronic migraines?

Research has shown that occipital nerve stimulation (ONS) might safely treat chronic migraines and related headaches. In studies, many patients reported long-lasting benefits from ONS with few side effects. For instance, one study found that after a year, patients still experienced pain relief without major issues. Another study tracked patients for a longer period and found similar results, suggesting that ONS remains effective and safe over time. While no treatment is completely risk-free, these studies provide reassurance about the safety of ONS for chronic headaches. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about occipital nerve stimulation for chronic migraines because it offers a unique approach compared to traditional treatments like medications and lifestyle changes. Unlike standard treatments, which often focus on managing symptoms through pharmaceuticals, this method directly targets the occipital nerve using an implant to potentially reduce migraine frequency and intensity. This innovative approach could provide relief for patients who haven't found success with existing options, offering hope for a more effective and targeted solution.

What evidence suggests that occipital nerve stimulation is effective for chronic migraines?

Research has shown that occipital nerve stimulation (ONS) can help reduce chronic headaches. In one study, about 45% of participants experienced a significant decrease in the number of severe headache days. Another study found that patients reported an overall improvement of about 31.7%. The treatment also provided lasting benefits for many, with fewer headaches and less intense pain. This trial will compare two different stimulation approaches: an industry-standard stimulation and an experimental sham stimulation. Although not everyone experienced improvements in past studies, the results are promising for those with chronic trigeminal autonomic cephalalgias (TACs). ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27475100/

Long-term outcomes of occipital nerve stimulation for ... Response rate of the whole group (defined as a >30 % reduction in monthly moderate-to-severe headache days) was observed in 45.3 % of the whole cohort, 34.3 % ...

2. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-016-0659-0

Long-term outcomes of occipital nerve stimulation for chronic ... Mean subjective patient estimate of improvement was 31.7 %. Significant reductions were also seen in outcome measures such as pain intensity ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10067723/

Long term outcomes of occipital nerve stimulation - PMC The response to ONS was sustained in the majority of patients with cluster headache with low rates of loss of efficacy in this patient population.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S109471591460012X

Long-Term Outcome in Occipital Nerve Stimulation ... In one of the 26 patients, success of ONS could not be determined. Among patients deemed to have successful outcomes, headache frequency decreased by 18%, ...

5. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/full/10.1111/head.14948

A multicenter, prospective, single‐arm study of 60‐day ... Most participants reported significant reductions in pain and/or pain interference following 60-day PNS targeting the occipital nerves. Outcomes ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25078718/

Safety and efficacy of peripheral nerve stimulation of the ... Conclusion: Our results support the 12-month efficacy of PNS of the occipital nerves for headache pain and disability associated with chronic migraine. More ...

7. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2023.1054764/full

Long term outcomes of occipital nerve stimulation The response to ONS was sustained in the majority of patients with cluster headache with low rates of loss of efficacy in this patient population.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715921064023

Safety and Efficacy of 10 kHz Spinal Cord Stimulation for ... 10 kHz SCS may a be safe and effective neurostimulation option for rCM patients. The paresthesia-free waveform constitutes an unprecedented advantage.