The Reed Procedure® Frequently Asked Questions

Dr. Reed’s research paper introducing the Reed Procedure® to the world of headache specialists earned the prestigious Cephalalgia Award, presented by the editors of Cephalalgia, the International Headache Society medical journal. The Cephalalgia Award is awarded every two years to the best paper published in Cephalalgia in the previous two years. In addition to receiving a certificate of award, Dr. Reed and Dr. Will were invited to present the paper at the International Headache Society’s annual congress in September 2009.

The International Headache Society comprises top neurology headache specialists from around the world. The journal receives hundreds of original articles each year from top academic centers, including Stanford, Cambridge, and Johns Hopkins.

The significance of the award and the publication of The Reed Procedure® paper, combined with the recognition it received from the medical community, shows the promise this procedure holds for future treatment of migraines and headaches.

The Reed Procedure® is a specialized neurostimulation treatment that provides relief from chronic, severe migraines and headaches. Here’s how it works:

Targeting Key Nerves:

Leads are implanted just beneath the skin in two critical areas:

• Supraorbital nerves (above each eyebrow): These address pain in the frontal regions of the head.
• Occipital nerves (at the back of the head): These target pain in the occipital and posterior regions.

This dual-target approach ensures coverage of head pain that can affect multiple regions simultaneously.

Neurostimulation Mechanism:

• The implanted leads deliver mild electrical impulses to the nerves, which disrupt the pain signals transmitted to the brain.
• The electrical stimulation also affects deeper brain centers involved in headache genesis, helping to reduce headache severity and frequency.

Pulse Generator:

• A battery-powered pulse generator is implanted under the skin, typically on the left side of the chest.
• Patients can control the stimulation using a handheld device, allowing them to adjust the intensity and location of the stimulation as needed.

Personalized Pain Management:

• During an initial trial phase, temporary leads are used to ensure the therapy is effective before the permanent system is implanted.
• The programming of the device is customized to the patient’s specific pain patterns and needs.

Safety and Long-term Efficacy:

• By targeting superficial nerves, the procedure minimizes risks while providing robust pain relief.
• Many patients experience a dramatic improvement in quality of life, with some becoming virtually headache-free.

In actual practice, the decision of what modality to use in an individual patient — ONS, SONS, or “Combined ON-SONS” — is based on where the patient feels the pain. If the pain is confined to solely the back of the head, then ONS alone should suffice. However, for patients that experience pain over both the back and front of the head, the “Combined ON-SONS” procedure (full Reed Procedure) is recommended.

Dr. Reed was actually the first physician in the world to do both procedures – ONS in 1992 and “Combined ON-SONS” in 2004. As such, he and the other RMC physicians that he personally trained are the world’s most experienced in both ONS and “Combined ON-SONS” (Full Reed Procedure).

The Reed Procedure® itself is not a medical device and, therefore, does not require FDA approval. However, it utilizes components such as neurostimulation leads and implantable pulse generators, which are FDA-approved medical devices. These devices are used off-label to treat chronic migraines and headaches in the Reed Procedure®.

Off-label use of FDA-approved devices is a common and accepted medical practice when a physician determines it is appropriate for a particular condition. The Reed Procedure® has been carefully studied and demonstrated as a safe and effective treatment for severe, refractory migraines and headaches.

Yes, there is a large and growing body of research, with over 100 papers published to date in peer-reviewed journals.

In fact, Dr. Reed published the original paper on the subject in his 1999 publication of “Occipital Nerve Stimulation for Occipital Neuralgia.” That paper started things out, and since Dr. Reed’s original paper, there have been a total of 111 published clinical reports on research conducted by 398 researchers representing 144 research institutions (71 in the US and 73 from across Europe and elsewhere). You may download the details of the papers and review the researchers and institutions by clicking this link: Reed Procedure Research.

Further, of these authors and institutions, Reed Migraine has taken a leadership position, noting the following landmarks:

1. Reed published the original paper on “Occipital Nerve Stimulation” (a component of the Reed Procedure) in 1999. All of the other papers follow his original report.
2. Reed published the original paper on “Combined Occipital and Supraorbital Nerve Stimulation” (the Full Reed Procedure) in 2009.
3. Reed partnered with several institutions, including the Mayo Clinic SW and Duke Medical Center, in the foundational prospective multi-center study on “Occipital Neurostimulation and Chronic Migraine” underwritten by St. Jude Medical and published in 2014.

If your neurologist hasn’t mentioned the Reed Procedure®, it could be due to several reasons:

Lack of Awareness: The Reed Procedure® is a specialized treatment, and not all neurologists may be familiar with it. Awareness of innovative treatments often depends on a physician’s exposure to certain fields, journals, or conferences.

Focus on Conventional Treatments: Many neurologists emphasize medical management and other well-established therapies before considering surgical interventions. If they believe standard treatments might still work for you, they may not explore or discuss advanced procedures.

Uncertainty About Candidacy: The Reed Procedure® is intended for specific cases, such as patients with frequent migraines (10+ headache days per month) that are unresponsive to at least six months of medical management. Your neurologist might not think you meet these criteria or may want to try other treatments first.

Regional Availability: The Reed Procedure® is offered at select centers like the Reed Migraine Centers in Dallas. A neurologist outside this area might not know its availability or have direct experience referring patients for this treatment.

If you believe this procedure might help you and your condition fits the criteria, bringing it up with your neurologist could be worthwhile. You can also explore completing the Reed Migraine Centers’ candidacy questionnaire or scheduling a consultation with Dr. Reed for a professional assessment.

The Reed Procedure® has been highly successful in treating almost all kinds of chronic migraines and headaches, including:

• Migraine Headaches of all types
• Chronic Migraine
• Chronic Daily Migraine
• Hemiplegic Migraine
• Abdominal Migraine
• Migraine with or without Aura
• Treatment-Resistant Migraine
• Refractory Migraine
• Intractable Migraine
• Any other migraine variation
• Headache after head or neck injury
• Cluster Headache
• Pseudotumor Cerebri (Normal Pressure Hydrocephalus; Elevated Intracranial Pressure)
• Arnold-Chiari Syndrome
• Occipital Neuralgia
• Post-herpetic Neuralgia
• Any other Face and Head Neuralgia
• Brain Aneurysm

While it’s essential to discuss the specifics of your medical condition with Dr. Reed, in general, yes, implanted stimulators have shown significant success in patients with:

• Diabetes
• Any type of shunt, such as “VP Shunt” or spinal fluid shunt
• History of repeated Lumbar Punctures (LPs)
• Aneurysms
• Pseudotumor Cerebri (Normal Pressure Hydrocephalus)
• Seizures
• Multiple Sclerosis
• Nerve Damage
• Previous nerve surgeries
• Any form of arthritis, including Rheumatoid Arthritis
• Fibromyalgia
• Existing implanted stimulators, like spinal cord stimulators
• Heart Conditions, including pacemakers

Having undergone unsuccessful migraine surgeries in the past does not automatically disqualify you from being eligible for the Reed Procedure®. The primary eligibility criteria for the procedure focus on your current condition and treatment history:

1. Chronic Migraine Frequency: You need to have at least 10 headache or migraine days per month.
2. Refractory to Medical Management: You must have tried at least six months of medical treatments (including prescription headache medications) without significant success.

If your previous surgeries were aimed at addressing migraines or related conditions, it’s essential to assess:

• Whether those surgeries targeted different mechanisms than the Reed Procedure® (which uses neurostimulation).
• Your current migraine patterns and severity.
• Any lingering effects from the previous surgeries that could affect the procedure’s efficacy or safety.

The Reed Procedure® specifically uses combined occipital and supraorbital neurostimulation to address chronic, severe headaches, making it distinct from most surgical migraine treatments. It is often considered for patients who remain debilitated despite other interventions.

Yes, the Reed Procedure® can address both migraine pain and associated symptoms, including auras, for many patients. The procedure works by using neurostimulation to target key nerves involved in migraine pathophysiology—the occipital and supraorbital nerves. This stimulation affects not only pain pathways but also deeper brain centers involved in headache genesis and modulation.

How It Helps:

Migraine Pain: The procedure is highly effective in reducing the frequency and intensity of chronic migraine pain. In clinical studies, patients with severe migraines often reported a significant or complete reduction in headache severity when both occipital and supraorbital nerve stimulation were used together.

Associated Symptoms: By modulating nerve activity and influencing deeper brain centers, the procedure can also alleviate other migraine symptoms, such as:

• Aura: While the aura originates from cortical spreading depression in the brain, the neurostimulation may help by interrupting the pathways that amplify migraine symptoms.
• Photophobia and Phonophobia: Sensitivity to light and sound can diminish as overall headache control improves.
• Nausea and Neurological Symptoms: Many patients report relief from nausea, visual disturbances, and even neurological deficits (e.g., hemiparesis) related to their migraines.

Limitations:

While the Reed Procedure® is highly effective for many patients, it may not completely eliminate all symptoms in every individual. The response varies based on factors such as the nature of the migraines, their triggers, and the patient’s overall neurological health.

In most cases, the implanted leads and battery are not noticeable under the skin. This discreet design ensures a natural appearance, allowing patients to go about their lives without visible signs of the device.

For the trial procedure, only a small area along the neckline is shaved. For the permanent procedure, about 1 to 1.5 inches of hair around the incision area and a small section above both ears are shaved. These areas are chosen to ensure that the incisions remain concealed by hair as they heal.

The Reed Procedure® does not have a strict age restriction; rather, candidacy is evaluated on a case-by-case basis. The most important considerations are the patient’s overall health, headache history, and ability to benefit from the procedure.

Key Factors Regarding Age:

Adults and Young Adults:

• The procedure is commonly performed on adult patients and has been successfully used for younger adults with chronic, debilitating migraines that have not responded to other treatments.

Children and Adolescents:

• While neurostimulation therapies like the Reed Procedure® are not typically the first-line option for pediatric patients, exceptions might be made for older adolescents with severe, refractory migraines. In such cases, a thorough evaluation is necessary to ensure the patient is both physically and psychologically prepared for the procedure. The youngest patient we have treated to date was 12 years old at the time of the procedure.

Elderly Patients:

• Older adults can be considered candidates if they meet the medical criteria (e.g., chronic migraines unresponsive to treatment) and are in good overall health. Factors like existing medical conditions or a history of surgeries may influence eligibility.

Individualized Assessment:

The decision to proceed with the Reed Procedure® is not based solely on age but on the treatment’s overall suitability for the individual’s condition. Consulting with a specialist at Reed Migraine Centers is the best way to determine if the procedure is appropriate for you or a loved one, regardless of age.

The Reed Procedure® carries risks common to all surgeries, including infection, although they are uncommon. Dr. Reed will address these risks and answer any questions during your initial consultation.

The Reed Procedure® is fundamentally different from most other migraine treatments because it targets the nerves associated with headache pain using a specialized neurostimulation system. Here’s how it sets itself apart: 

Key Differences:

Targeted Nerve Stimulation:

The Reed Procedure® involves the implantation of leads that deliver mild electrical pulses to the occipital and supraorbital nerves, which are associated with headache pain. This dual stimulation approach is unique, as it addresses pain in both the front and back of the head.

By modulating nerve activity, the procedure directly interrupts the pain signals responsible for migraines.

Deep Brain Impact:

While the leads stimulate peripheral nerves, studies show the electrical impulses also influence deeper brain centers involved in headache modulation. This dual mechanism helps reduce both the occurrence and severity of migraines.

Long-Term Relief:

Unlike medications that provide temporary relief or prevent symptoms only while taken, the Reed Procedure® offers long-term results. Many patients experience a significant reduction in both the frequency and intensity of migraines, with sustained relief over years.

Minimal Reliance on Medications:

Patients often reduce or eliminate their dependence on headache medications, which can come with side effects and risk of overuse headaches.

For Refractory Cases:

The procedure is designed specifically for patients who have not responded to traditional treatments, such as prescription medications, Botox injections, or nerve blocks.

Non-Destructive and Adjustable:

Unlike surgeries that remove or sever nerves, the Reed Procedure® is reversible and adjustable. The neurostimulator can be reprogrammed to optimize effectiveness without further surgery. 

Why It Could Work for You:

• If you’ve tried standard migraine treatments (medications, lifestyle changes, injections, or other procedures) without success, the Reed Procedure® addresses the condition in a different way by focusing on nerve and brain signal modulation.
• This approach is ideal for individuals with chronic, debilitating migraines that interfere with daily life and have been resistant to other therapies.

1. Prescription Medications

• Purpose: Medications (e.g., triptans, CGRP inhibitors, or beta blockers) aim to prevent migraines or abort an attack once it starts.
• Challenges:
  • Effectiveness varies; many patients find limited or temporary relief.
  • Risk of side effects, including fatigue, nausea, and cognitive issues.
  • Overuse can lead to medication overuse headaches (rebound headaches).
• Reed Procedure® Advantage:
  • Provides long-term relief without relying on daily medications.
  • Patients often reduce or eliminate medication use, avoiding side effects and dependency.

2. Botox Injections

• Purpose: Prevent migraines by relaxing muscles and modulating nerve activity.
• Challenges:
  • Requires regular treatments every 3-4 months.
  • Effectiveness may diminish over time.
  • Only suitable for certain migraine types.
• Reed Procedure® Advantage:
  • A one-time implantation with long-term effectiveness.
  • Directly targets nerve pathways and deeper brain centers responsible for migraines, not just muscle tension.

3. Nerve Blocks

• Purpose: Temporary pain relief by numbing occipital or other cranial nerves.
• Challenges:
  • Relief is short-lived (weeks to months).
  • Requires repeated procedures and may lose effectiveness over time.
• Reed Procedure® Advantage:
  • A permanent solution that provides continuous nerve modulation without the need for repetitive interventions.

4. Ablative Surgeries (e.g., Nerve Decompression or Severing)

• Purpose: Permanently remove or decompress nerves to alleviate pain.
• Challenges:
  • Irreversible and potentially risky (e.g., nerve damage, persistent pain, or loss of sensation).
  • May not address the root cause of migraine pain, especially if pain pathways remain active.
• Reed Procedure® Advantage:
  • Non-destructive and adjustable. The implanted neurostimulator can be reprogrammed for optimal effect without additional surgery.
  • Reversible if needed, preserving nerve function.

5. Other Neurostimulation Options

• Purpose: Various devices provide electrical stimulation to reduce headache frequency or severity (e.g., vagus nerve stimulators, single-site stimulators).
• Challenges:
  • Some target only one nerve area (e.g., occipital nerve stimulation).
  • Less effective for complex migraines involving multiple pain regions.
• Reed Procedure® Advantage:
  • Combines occipital and supraorbital nerve stimulation, addressing both front and back headache pain, as well as holocephalic (whole-head) migraines.
  • Designed specifically for chronic, severe migraines, making it more comprehensive.

Summary of Reed Procedure® Benefits:

• Comprehensive Approach: Targets pain pathways at both the nerve and brain levels.
• Long-Term Effectiveness: Sustained migraine relief with proper neurostimulator use.
• Adjustable and Reversible: Offers adaptability without compromising nerve function.
• Medication Reduction: Decreases reliance on pharmaceuticals and their side effects.

The Reed Procedure® is a transformative treatment that stands apart from external stimulators like TENS units, Cefaly®, or Relivion®. While these external devices may be worth exploring, they often provide limited relief and work on preset programs that attach to the forehead and run for a fixed duration, which may not address individual needs effectively.

In contrast, the Reed Procedure® features a neurostimulator with real-time, customizable programming tailored to each patient’s specific requirements. This device can be used continuously and adjusted conveniently via a phone app, offering unmatched flexibility and control. Many patients, including those who found little or no benefit from external stimulators, report life-changing results with the Reed Procedure®.

This personalized, adaptable approach makes the Reed Procedure® a highly effective and responsive solution for managing chronic migraines and headaches.

To determine if your insurance covers the Reed Procedure®, Reed Migraine Centers conduct a thorough verification process before scheduling your complimentary phone consultation with Dr. Reed. This process includes:

1. Collecting Insurance Details: You provide your insurance information to the Reed Migraine Centers team.
2. Reviewing Coverage: The team evaluates your benefits to check if the Reed Procedure® is included in your plan.

This step ensures you have clarity on coverage before moving forward with consultations or treatments.

It usually takes insurance companies up to 30 business days to make a decision regarding the approval of the procedure. On average, patients can expect to hear back from their insurance provider about the decision in approximately 3 weeks.

The Trial Procedure and the Permanent Procedure for the Reed Procedure® differ primarily in purpose, process, and duration. Here’s a detailed comparison:

Trial Procedure

Purpose:

A temporary evaluation to determine if neurostimulation effectively alleviates your headaches.

Allows patients to “test drive” the treatment before committing to a permanent implant.

Process:

Leads are temporarily placed under the skin along the occipital and supraorbital nerves.

The leads are connected to an external neurostimulator device worn outside the body.

The trial period lasts about 3–5 days.

Leads are removed after the trial, regardless of whether it is successful.

Reversibility:

Completely reversible since no components are implanted.

Permanent Procedure

Purpose:

A long-term solution for managing severe, chronic migraines after a successful trial procedure.

Process:

Leads are permanently implanted beneath the skin along the occipital and supraorbital nerves.

A small battery-powered pulse generator device is permanently implanted under the skin, typically on the left side of the chest.

The procedure is minimally invasive but requires general anesthesia.

Reversibility:

Designed for permanent use, although adjustments or removal are possible.

The Trial Procedure is a crucial step before the Permanent Procedure because it ensures that the Reed Procedure® is effective and suitable for each individual patient. Here’s why it’s necessary:

Evaluation of Effectiveness

The trial allows you and your medical team to determine if neurostimulation significantly reduces your headache frequency, severity, or duration.

A successful trial is defined as at least 50% improvement in headache symptoms.

Personalized Experience

It provides firsthand experience of the neurostimulation effects, helping you understand how the therapy might feel and function in daily life.

Feedback from the trial period helps optimize the programming for the Permanent Procedure.

Avoids Unnecessary Surgery

The trial ensures you won’t undergo a permanent surgical procedure unless there’s clear evidence that the therapy will benefit you.

It minimizes risks by selecting only patients who respond well to the treatment.

Informed Decision

By experiencing the temporary system, you can make a confident and informed choice about whether to proceed with the permanent implant.

Customization

The trial helps the medical team determine the best placement and settings for the permanent leads and device.

The information from the trial is used to fine-tune the permanent system for maximum efficacy.

The trial procedure ensures that patients who proceed with the permanent implant have a high likelihood of success, making it a thoughtful and patient-centered step in the process.

Typically, after the trial procedure, you’ll have a follow-up to discuss your experience and the effectiveness of the trial. If it’s successful and you opt for the permanent implant, Reed Migraine Centers will seek prior authorization from your insurance company, which may take up to 30 business days. Once approved, the permanent procedure will be scheduled.

Stage 1: Resuming Light Daily Activities
Most patients are able to resume light daily activities within 2 to 3 days following the procedure. While some discomfort may occur, it is typically manageable with prescribed medications. Light activities may include simple household tasks, cooking, and other non-strenuous routines.

Stage 2: Returning to Office Work or School
Patients can usually return to office work or school within 1 to 2 weeks after the procedure. This recovery period helps ensure that any initial discomfort has subsided, allowing patients to comfortably engage in sedentary activities.

Stage 3: Engaging in Strenuous Activities
Strenuous activities, such as sports or intense exercise, should be avoided for approximately 6 weeks post-procedure. This extended recovery period is essential for proper healing and reducing the risk of complications or setbacks.

No, undergoing an MRI with an implanted metal device, such as the neurostimulator used in the Reed Procedure®, is generally considered unsafe due to the strong magnetic fields involved. This limitation, however, seldom poses significant issues because alternative imaging options, such as CT and PET scans, are often sufficient to meet diagnostic needs.

If an MRI is absolutely necessary, a temporary removal of the neurostimulator may be arranged, followed by reimplantation after the MRI is completed. This process requires coordination with your medical team to ensure safety and proper care during and after the imaging procedure.

Patients are generally encouraged to avoid strenuous activities, such as contact sports, for about six weeks following the procedure to promote proper healing. Beyond this precaution, most patients report little to no physical restrictions afterward. In fact, many feel a renewed sense of freedom from chronic, severe head pain and can once again enjoy activities they previously had to forgo.

No, you should not experience any issues with airport travel scanners after the procedure. TSA screeners are well-trained to accommodate travelers with medical implants, such as pacemakers and neurostimulators. They can efficiently perform screenings using a standard scanner or a handheld wand. Additionally, patients receive a card identifying them as having an implanted neurostimulator, ensuring a seamless screening process.

The device used in the Reed Procedure® is designed for long-term use, with a typical battery lifespan of 8 to 10 years. When the device needs to be replaced at the end of its life, the process is straightforward and involves an outpatient procedure. This ensures that you can continue receiving effective relief from chronic migraine and headache pain without significant interruptions.

The implanted battery used in the Reed Procedure® is rechargeable and designed to last between 8 to 10 years. When replacement is needed, the process can be completed with a straightforward outpatient procedure, ensuring continued long-term relief from chronic migraines and headaches.

If you experience any issues with your device, we encourage you to contact your device representative directly for assistance. If their contact information is unavailable, you are welcome to contact Reed Migraine Centers for help. Our team is also available to provide support for any medical concerns related to your device.