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Reed Migraine Centers * Founders and Inventors of the Reed Procedure | 4-Lead Procedure | » FAQs

Reed Migraine Centers FAQs – Migraine Treatment & Relief

The Reed Procedure ® : A Permanent Surgical Migraine Treatment

Reed Migraine Centers FAQs are dedicated to answering some common questions about The Reed Procedure ® and the 4-Lead Procedure, the revolutionary migraine treatment invented by Kenneth Reed, M.D.

Some topics include occipital nerve stimulation, trial stimulator, and a general reference for what the Reed Procedure ® is and how it works. The FAQs are organized by category. Note that on the Video FAQs page, Dr. Reed answers related questions. If you have any other questions that are not answered by these FAQs, please contact us via this website or contact a patient coordinator directly at 972-707-2800 or after hours at 972-922-1692.

The Reed Procedure ®

What is the Reed Procedure ®?
In the Reed Procedure ®, an implantable neurostimulator is placed underneath the skin at the target areas to control migraine headaches. Similar to a pacemaker’s purpose for the heart, where a small battery is placed under the skin and a tiny wire passes up to the heart to pace it, the same is true for the implantable neurostimulator. For headache sufferers, tiny wires pass underneath the skin to superficial locations in the head, and once turned on, effectively stop the headache. The success rate is over 80%. The battery lasts up to 10 years and when in need of replacement, consists of a quick 30-minute procedure. The implantable neurostimulator is completely reversible and can be removed at any time.
How does the Reed Procedure ® work?
The battery generates a mild, electromagnetic field at the tip of a long wire, connected to the small battery pack, and emits electrical pulses to the superficial nerves in the forehead and back of the head. Headache pain is then replaced with a tingling or massaging sensation almost instantly. Medical studies show that while the device is stimulating the superficial nerves, it is also stimulating deep centers in the brain related to the areas important in the modulation and genesis of headaches. Thus, the neurostimulator works in a very safe fashion to stop or prevent headaches from occurring altogether. For patients who positively respond to the trial procedure and move forward with the permanent unit, the response is dramatic and results are often immediate.
Am I a candidate for the Reed Procedure?
The RP is recommended for patients who have frequent, severe headaches that have not responded to other treatments. We generally ask that two criteria be met:

  • You have 2 or more severe headaches a week, and
  • You have tried at least 3 months of medical management (headache medications) and nothing is working.
I’ve heard of Occipital Nerve Stimulation. Is the Reed Procedure basically the same thing?
Occipital Nerve Stimulation (ONS), which is an implanted unit that stimulates the nerves over the back of the head (occiput), is actually a component of the full Reed Procedure. The other component of the full procedure is Supraorbital Nerve Stimulation (SONS), which results in stimulation of the nerves over the forehead (supraorbital region). Therefore, the medical term for a full Reed Procedure is “Combined Supraorbital and Occipital Nerve Stimulation.”

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).

Is the Reed Procedure FDA approved?
The implantable neurostimulator devices that we use today are manufactured by St. Jude Medical, Boston Scientific, and Medtronic Corp and have been fully FDA approved devices for over 40 years for chronic back and neck pain.

And, after over 2 decades of use, the neurostimulator implant procedures that we use are accepted as a standard of care across the medical community, as an “off label” application for chronic head pain.

Further, Medicare and most commercial and national carriers now approve implantable peripheral neurostimulation for various types of chronic head pain and/or headaches. For example, Medicare’s national policy indeed now fully approves implantable neurostimulation for treatment-resistant chronic migraines.

Is there medical research in peer-reviewed journals on the Reed Procedure?
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:

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.
Reed published the original paper on “Combined Occipital and Supraorbital Nerve Stimulation” (the Full Reed Procedure) in 2009.
Reed partnered with several in 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.

Reed Migraine Centers

Why Choose Reed Migraine?

Reed Migraine is home to the world’s most experienced physician specialists for the treatment of migraine by implantable neurostimulation. Dr. Reed and his partners literally invented the foundational implantable neurostimulation procedure, known as the Reed Procedure, that is currently being used around the world today. We thus have the longest experience (over 25 years) of any specialists in the world. In addition to being the world’s most experienced specialist, Dr. Reed continues to publish original research on the subject, and he lectures and trains physicians around the world.

What is the Cephalalgia Award that Dr. Reed won in 2009?
Research by Kenneth Reed, M.D earned the prestigious Cephalalgia Award, presented by the editors of Cephalalgia, the medical journal of the International Headache Society. In addition to receiving a certificate of award, Dr. Reed and Dr. Will were invited to present the paper to the annual congress of the International Headache Society, which occurred 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 head pain.

Can I hear about it from a patient?
Yes. Some of our patients have said they’ve been given their life back after having the neurostimulator implanted and are now stepping outdoors for the first time and spending time with friends and family. They are simply overjoyed by the whole process. While the major focus is on the treatment of headaches, there are a lot of complimentary benefits included, as well. As professionals in pain management, we also find it to be very gratifying to know our patients are now able to experience their life in a brand new way and participate in normal, daily activities they never thought were possible before having The Reed Procedure ®.
What is a Patient Ambassador?
A Patient Ambassador is a patient who has undergone The Reed Procedure ® and can offer insight to other patients who are thinking about both the trial and permanent implant. Our Patient Ambassadors are happy to meet patients and share their own experiences about having gone through the procedure themselves. We encourage any candidates or patients of The Reed Procedure® to look into this program and share their story with others.

Insurance

Is the Reed Procedure® covered by insurance?
Yes. Please refer to our insurance page for more information: https://reedmigraine.com/insurance/

Reed Migraine’s Insurance Specialists have over 25 years of experience in successfully working with all of the carriers with respect to verifying benefits and obtaining precertification for the procedure. We pride ourselves on complete transparency here and our specialists will keep you updated throughout the process. The key point here is that you will have confirmation of insurance coverage prior to any procedures.

Clinical

Can I qualify even if I have had other surgeries for migraines and they haven’t helped?
Yes, we have had success with many patients that have had various types of surgical procedures for their migraines. These procedures often include ablation (cutting) the nerves of the head or any other type of surgical intervention specifically on the nerves. If you continue to experience significant head pain after other surgical procedures, then we recommend that you schedule a (complimentary) appointment with one of our Reed Migraine physician specialists to review your individual situation in more detail.
Will this help my type of headache?

Implanted Neurostimulation (Occipital Nerve Stimulation, the Reed Procedure) has been demonstrated successful for virtually all types of chronic head pain including:

  • Migraine Headaches (all types)
  • Chronic Migraine
  • Chronic Daily Migraine
  • Hemiplegic Migraine
  • Migraine with Aura and without Aura
  • Refractory Migraine
  • Any other type of Migraine Headache
  • New Persistent Daily Headache
  • Migraine (or any Headache) that occurs 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 type of Neuralgia of the Face and Head
  • Brain Aneurysm
I have one of the following medical conditions. Is it still okay for me to have the Reed Procedure?
While you should consult with the physician about the specifics of any medical condition, in general, yes, implanted stimulators have proven very successful in patients with:

  • Diabetes
  • Any type of shunt, including “VP Shunt” or spinal fluid shunt
  • Have undergone repeated Lumbar Punctures (LPs)
  • Aneurysms
  • Pseudotumor Cerebri (Normal Pressure Hydrocephalus)
  • Seizures
  • Multiple Sclerosis
  • Nerve Damage
  • Had prior surgery on any nerves
  • Any type of arthritis, including Rheumatoid Arthritis
  • Fibromyalgia
  • Have another implanted stimulator, e.g., spinal cord stimulator
  • Heart Conditions, including pacemakers
Does the Reed Procedure help Hemiplegic Migraine?
Yes. We have treated many patients with Hemiplegic Migraine, and they have seen excellent results. In addition to reporting relief from their migraines, they also found that the associated hemiplegic weakness or numbness was also relieved.
In addition to the Migraine, I get “auras”, which can be flashing lights, partial loss of vision, numbness, weakness, bad smells, and other symptoms. Does the RP help with just the migraine pain, or does it also help with some of these other associated symptoms (auras)?
Yes, in addition to relieving the migraine pain, the RP typically also relieves associated symptoms, including auras.
What are the risks or downsides?
Neurostimulation is a standard, well-accepted treatment that’s been around for a long time. While it involves a relatively small battery under the skin, there are minimal risks or downsides involved. The Reed Procedure® is a two-step process, with the trial being the first step. The upside to the trial is very clear, in that if it works, the patient will be very happy with the end result. There’s also no physical downside or limitations that come along with the trial or permanent procedure. It cannot make headaches worse or hurt the nerves. However, one downside is if the patient falls into the twenty percent of those in which the trial does not work. Then, of course, the patient is disappointed. As for the permanent procedure, there is a small risk of infection, much like with any surgical procedure, but it is treatable.
Can I have an MRI if I have the Reed Procedure ®?
No, you cannot have an MRI if you have any implanted metal unit, such as a stimulator. However, while certainly a consideration, the issue rarely poses any problem, as alternative radiographic options can often be used in place of the MRI – such as the CT and PET scans. In fact, having performed hundreds of implants over the past 25 years, we have only encountered one instance where the patient specifically required an MRI. In that case, we were able to remove the stimulator temporarily, enabling the patient to have the MRI, whereupon we promptly replaced the stimulator afterward.

Trial Stimulator

Why is the trial done?
With the test stimulator, we implant a temporary unit, which is much like an IV tube underneath the skin, and leave it in for a few days to see if the patient stops feeling the headaches. If the unit works, it does so both dramatically and immediately. The patient will return to the office three to seven days later and tell us if it worked. The trial is a medical procedure performed in the outpatient setting at the hospital and takes 15 minutes. During this completely painless procedure, the patient is given an IV sedative, and once asleep, a tiny IV tube is placed above each eyebrow and two more are placed in the back of the head. There is no incision during the trial. When the patient wakes up, they have tape over the upper eyebrow area and small wires sticking out from underneath that plug into a battery box located outside of the body. Once in the recovery room, a representative from Reed Migraine Centers will turn on the system, and the patient will begin to feel a mild, tingling sensation in the forehead, as well as in the back of the head. The patient will then go home wearing the temporary unit for three to seven days. Typically, there are dramatic effects and the patient will know, with a high degree of certainty, whether or not the procedure will work right away. The patient will return after the trial period and the temporary unit will be removed. If the patient does not see a dramatic change in their headaches the patient is not a candidate for The Reed Procedure®. If it did work, then the patient moves forward with a permanent stimulator implant scheduled within a couple of weeks from the trial date. With the ability to test the implanted neurostimulator, we are highly confident that the permanent stimulator will work effectively on the patient.
What happens during the trial?
The test stimulation shows the patient exactly how a permanent stimulator feels. During the seven day trial period, it will be easy for the patient to determine whether or not they feel a difference in the severity of their headaches. The trial is conclusive and has also been proven to work more than 80 percent of the time. Therefore, if the trial works for patients, then the permanent procedure will work and continue to work. When the patient goes home during the trial period, we encourage them to go through normal activities. The wires can be placed beneath the patients clothing, so as not to distract them from going about regular day-to-day activities. The trial pack can be fixed to the beltline, as well. We strongly suggest our patients try to trigger a headache while in the trial period to determine the true effectiveness of the stimulator. For instance, if sunlight normally triggers a patient’s headache, we tell them to go out in the sunlight to test the effectiveness of the stimulator.

Lifestyle

Will it cause physical limitations?
There are commonly no cosmetic side effects. In general, friends and family cannot tell that the patient has a unit implanted. Physical limitations are practically non-existent in our patients. In fact, the exact opposite has been found to be true. Having the unit implanted and no longer having to deal with chronic headaches allows our patients to feel liberated. They can now do things they couldn’t do before like go outside, enjoy physical activity, eat trigger foods that they couldn’t before, and can resume their life after having the permanent procedure.
Are there any problems with travel, such as with scanners at airports?
No, there are absolutely no issues. The TSA screeners are very experienced in working with travelers who have implants (pacemakers, implanted stimulators, etc.). They are able to scan (or “hand wand”) for these without difficulty. Additionally, all patients have a card that they can carry identifying them as having an implanted neurostimulator; however, even without the card, there is no problem at all with TSA screening.
I live out of town. How much travel and what is involved in getting a stimulator?
As we see patients from across North America, the majority of our patients actually do come from “out of town.” As such, we have developed a smooth process to accomplish our goal of getting your headaches under control that involves 2 separate trips to Dallas:

  • Trip 1. This is for placement of the Trial Stimulator and it requires you to stay in a Dallas hotel for 2 nights. After these first 2 days, you may return to your hometown for the duration of the 7-day trial. (Any nurse or physician in your hometown can easily remove the trial stimulator in the office.)
  • Trip 2. This is for the placement of the Permanent Stimulator, and it requires you to stay in a Dallas hotel for 3 nights. After placement of the permanent unit, there is generally no need for any planned further trips to Dallas, as your local physician can handle everything from there. Basically, once the unit is implanted and has healed, then typically there is actually no reason to see a physician. That is one of the many beauties of an implanted stimulator – you simply do not need to go back and forth to the doctor’s office. Now, we are available 24/7 should you have any questions or issues, but barring something very unusual and unexpected, there will be simply no reason to return.

Important Note: The trial stimulator procedure may be performed in Dallas, New York City, Chicago, and Miami. All permanent stimulator placements are performed only in Dallas.

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