Neuromodulation as a Treatment for Migraine

13th October 2017

Neuromodulation as a Treatment for Migraine

The International Neuromodulation Society describes neuromodulation as… “technology that acts directly upon nerves. It is the alteration—or modulation—of nerve activity by delivering electrical or pharmaceutical agents directly to a target area”

There are several methods of neuromodulation or stimulation used in the treatment of migraine. They each target a different area and are used in different ways and they are mostly non-invasive. Please click on a link below to find out more about these neuromodulation treatments for migraine.

  • Transcranial Magnetic Stimulation (TMS)
  • Transcutaneous Electrical Nerve Stimulation (TENS)
  • External Trigeminal Nerve Stimulation (eTNS)
  • Vagus (Vagal) Nerve Stimulation (VNS)

Transcranial Magnetic Stimulation (TMS)

What is TMS?

Transcranial Magnetic Stimulation involves the use of magnetic pulses delivered to the brain via a device which does not touch the skin or scalp. The magnetic pulses cause tiny electrical currents in the brain tissue which modify and excite neurons. According to eNeura “This process is thought to interrupt the abnormal electrical activity associated with migraine and cortical spreading depression (CSD)”.

TMS Device

‘eNeura’ is one of the companies that supplies a TMS device. It is currently available in the US and UK. Their ‘Spring TMS’ device is small, portable and delivers a mild and brief pulse of magnetic energy to the back of the head. If the first pulse fails, it can be used again, with only a short interval between pulses (for the device to recharge). It is quick and easy to use. It is only available on prescription, and currently only from the UK or US. For more on how it works and how to go about getting a prescription, go to the eNeura website They have a video with instructions on its use. For information on how to get one of these devices, see the following PDF

MAI recently spoke to a representative from eNeura and are hopeful that this device will soon be available in Ireland. At the moment, Irish patients can be prescribed its use but only if they are referred to places such as King’s College London where Professor Peter Goadsby and his colleagues currently prescribe the device.

When the doctor sends your prescription (on a form filled out by both you and them) they send it to eNeura who send you the device along with an SD card or SIM card which has your individual programme on it. When you get the device you insert the card into the device and turn it on. There is a nurse advice line available for training and help (which you must go through), then you can get zapping!

Are there Side-effects?

Like all migraine treatments, there is an element of risk from side-effects with TMS. Generally TMS is well tolerated and little or no side-effects are reported. However, at the moment there is no data about the long-term effects of TMS. Immediate side effects may include minor vertigo or dizziness, nausea, slight pain at the sight of the pulse, tingling.

There are a lot of factors to consider when thinking about using a TMS device. eNeura have a list of warnings, precautions and contraindications that come with their ‘Spring TMS device. These are not to put people off just to make them fully aware of and comply with the safe use of the system.

Warnings about when not to use the device include but are not limited to;

  • Near flammable gases or petrol
  • When it’s wet, or near water
  • During the Aura phase of your attack, use when the pain hits
  • It doesn’t work on Cluster Headache

Precautions to keep the device at least 2 feet away from certain objects when it’s on include but are not limited to;

  • Mobile phones
  • Wireless network routers
  • Cordless telephones and their bases
  • Credit Cards
  • Computer
  • Flash memory sticks
  • MP3 players
  • Digital cameras
  • Glasses
  • Keys
  • Coins
  • Jewellery
  • Watches

Contraindications include but are not limited to having any or all of the following implants;

  • Pacemaker
  • Implanted Vagus Stimulator
  • Aneurysm clips or coils
  • Cochlear Implants
  • Stents
  • Filters
  • Any implanted medical device with metals of conductive materials

You can continue to use your normal migraine medications while using the TMS device but you should regularly consult with your doctor.

How much does it cost and how do I get it?

The TMS device is prescription only and cannot be bought, but can be rented from eNeura in the UK for;

  • 3 months @ £499 Sterling
  • 6 months @ £900 Sterling
  • 1 Year @ £1,611.60 Sterling

After you and your doctor fill out the necessary forms, you need to fill out a rental agreement form. You send it all off and as I mentioned above, eNeura will send you the device along with an SD card or SIM card which has your personal treatment plan on it.

You must always discuss it with your doctor when embarking on a new treatment plan.

 

Transcutaneous Electrical Nerve Stimulation (TENs)

What is TENs?

Aside from being difficult to say, Transcutaneous Electrical Nerve Stimulation more or less does what it says on the tin. Transcutaneous means literally ‘through the skin’ and it delivers mild electrical pulses through the skin via electrodes that are inside adhesive gel pads. These pads are stuck to the skin in the area required and the device is then used to the individual specifications of the sufferer. According to ‘Patterson Medical’ a company that makes TENs machine “TENs works by a method called pain gating where the stimulation of the TENs machine blocks the messages to the brain telling it the body is experiencing pain. It also encourages the brain to produce the body’s own natural painkilling hormones known as endorphins.”

TENs Device

There are hundreds of different kinds of TENs machines, some are as small as, or even smaller than a mobile phone, others look more like Mr. Spock’s Tricorder from ‘Star Trek®’, but each one acts in much the same way. For the sake of this ezine I’ve chosen the Patterson Medical TPN200 PLUS to look more closely at.

To get the best results, the electrodes should be placed over the area of pain and then treated for 30 – 60 minutes, depending on the area and tolerance. Many of the TENs machines can be programmed with different frequencies, different treatment options and some include a relaxation programme and some can target specific acupressure or acupuncture points on the body. Most come with a belt or lanyard so you can move around while being treated.

The TPN 200 Plus is available in Ireland and you can be ordered over the net. Again, caution must be used and you should consult your GP or Neurologist before using such a device.

Are There Side-effects?

Again the Precautions include but are not limited to;

  • Patients with an implanted electronic device (for example, a pacemaker) should not undergo TENs treatment without first consulting a doctor. The same applies to patients with any metallic implants.
  • If TENs therapy becomes ineffective or unpleasant, stimulation should be discontinued until its use is re-evaluated by the physician or therapist.
  • Avoid adjusting controls while operating machinery or vehicles.
  • Turn the TENs off before applying or removing electrodes.
  • Do not use it in the presence of explosive atmosphere and flammable mixture.

The warnings include but are not limited to;

  • Caution should be used in applying TENs to patients suspected of having heart disease. Further clinical data is needed to show there are no adverse results.
  • Electrical stimulation safety has not been established during pregnancy.
  • Do not use TENs during pregnancy.
  • Do not place electrodes on the front of the throat as spasm of the Laryngeal and Pharyngeal muscle may occur
  • Do not stimulate over the carotid nerve,
  • Cases of skin irritation at the electrode site have been reported.
  • Electrodes should not be placed over the eyes, in the mouth, or internally.

You can continue to use your normal migraine medications during use of the TENs machine but you should regularly consult with your doctor.

How much does it cost and how do I get it?

TENs devices cost different amounts of money and can be reasonably priced or very expensive. It depends on what you want. You can go to some pharmacies and buy the directly from them or you can order others on the internet. It’s basically up to you to decide what you need. Just remember that with a TENs device, you will at some stage need to buy replacement pads and these come with their own price tags.

Assist Ireland have a list on their website of various available TENS Devices

Remember to always discuss it with your doctor when embarking on a new treatment plan.

 

External Trigeminal Nerve Stimulation

What is eTNS?

External Trigeminal Nerve Stimulation (eTNS) involves administering precise micro-pulses of electricity to the Trigeminal Nerve. The trigeminal nerve is responsible for feelings and sensations in the face and is the largest of the cranial nerves (nerves that extend directly from the brain). It’s thought to be one of the most common factors involved in the pain of migraine. It’s made up of three branches: the ophthalmic (area around the eyes), maxillary ( area around the nose), and mandibular ( area around the jaw) nerves. According to Cefaly who make the Cefaly eTNS Device – “Neurostimulation of the trigeminal nerve with Cefaly produces a sedative effect. Regular repetition of this sedative effect helps reduce the number of attacks of migraine.”

eTNS Device

There are a few eTNS devices, but the one MAI has seen most of is the Cefaly device. This device uses an electrode which is positioned and stuck to the forehead. The Cefaly device itself connects to the electrode and “generates precise micro-impulses in order to stimulate the nerve endings of the trigeminal nerve” The electrode can be used up to 20 times. The Cefaly device is promoted as a preventative device not an abortive one so you use it every day to try to reduce frequency and severity. A typical session takes about 20 minutes and this would be one session every day. The intensity can be adjusted so that you are comfortable with the level of the pulses.

It has a setting for ‘Crisis Treatment’ so you can use it to help during an attack, but it also has an ‘Anti-stress’ setting which you can use to relax you between preventative sessions.

The Cefaly device can be bought via the Cefaly website, along with the electrodes. It doesn’t require a prescription for use, however, as it uses electrical energy, you should still consult with your doctor before using the device as it too is contraindicated in certain circumstances.

Are there Side-effects?

According to Cefaly, the sensation when using the device is strange and unusual, but most people get used to it after a few sessions. However some people are more sensitive and may find the sensation produced by the Cefaly painful. In this case you can try to lower the intensity to a more comfortable level which might help. If you find that you can’t use it, then stop straight away and return it to Cefaly or contact them through the numbers on their website. If you need to return it, you must make sure it’s in perfect condition and with its original packing within 14 days for a refund on the price. Cefaly has been passed as safe for use during pregnancy, but again a doctor’s supervision is recommended.

It comes with the following warnings and contraindications; Do not use the Cefaly device if;

  • you have an implanted metallic or electronic device in the head
  • you suffer from pain of unknown origin
  • you have a cardiac pacemaker or implanted or wearable defibrillator. This may cause interference with pacing, electric shock, or death
  • You can continue to use your normal migraine medications during use of the eTNS device but you should regularly consult with your doctor.

How much does it cost and how do I get it?

The Cefaly device can be bought over the Cefaly website via this link. It currently costs €295 for the device and between €19 and €24 the electrodes depending on which ones you choose. Again, there is no need for a prescription but…

Always discuss it with your doctor when embarking on a new treatment plan.

 

Vagus (Vagal) Nerve Stimulation (VNS)

What is VNS?

VNS is the use of electric currents to stimulate the vagus nerve. This nerve is the longest and most connected nerve in the body which starts at the brain stem and ends near your bowels. Electrical stimulation of the vagus nerve has been going on for years, used for disorders such as depression and epilepsy. The electrical impulses from a VNS device are applied through either electrodes implanted beneath the skin, or without implants via the direct contact with the skin. Electrocore, the makers of the gammaCore device say “It is not certain how vagus nerve stimulation treats and prevents migraines and cluster headaches, but data suggest that it may work by sending signals into the brain that reduce the amount of a chemical called glutamate, that has been associated with headache symptoms.”

VNS Device

The gammaCore device is the first of its kind; a hand-held device about the size of a mobile phone that generates a unique electrical signal which targets the vagus nerve. It’s non-invasive  –  so no implants needed and can be used to treat migraine, cluster headache and other headache disorders. A conductive gel is applied to the two ‘stimulation surfaces’ of the device and it’s placed on the neck. Each dose takes approximately 2 minutes

See the video below from the gammaCore website for more information on this device.
https://youtu.be/TZsXg0fr_fg

Are there Side-effects?

So far any side-effects noted are mild, and usually stop when treatment is finished.

The precautions include but are not limited to;

  • Hoarseness
  • Shortness of breath
  • Change in voice
  • Tingling/pricking feeling where the device is applied
  • The warnings include but are not limited to; – do not use if you have
  • A pacemaker,
  • Hearing aid implant,
  • Any implanted electronic device.
  • Been diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Had surgery to cut the vagus nerve in your neck.

How much does it cost and how do I get it?

The gammaCore device can only be got by applying through your doctor. It will require your GP to fill out an authorisation form and send it off to gammaCore. They will send the device either to your home or your doctor’s clinic. Both you and your doctor can avail of the training portal so that both of you can ensure you use the device most effectively. You buy a certain amount of doses at a time, either 150 doses or 300 doses. When you are finished all your doses, you must get a new device and dispose of the old one. Prices may have changed but last known prices were;

  • 150 doses £250 Sterling
  • 300 doses £500 Sterling

Always discuss it with your doctor when embarking on new treatment plan.

Neuromodulation as a Treatment for Migraine

13th October 2017

Neuromodulation as a Treatment for Migraine

The International Neuromodulation Society describes neuromodulation as… “technology that acts directly upon nerves. It is the alteration—or modulation—of nerve activity by delivering electrical or pharmaceutical agents directly to a target area”

There are several methods of neuromodulation or stimulation used in the treatment of migraine. They each target a different area and are used in different ways and they are mostly non-invasive. Please click on a link below to find out more about these neuromodulation treatments for migraine.

  • Transcranial Magnetic Stimulation (TMS)
  • Transcutaneous Electrical Nerve Stimulation (TENS)
  • External Trigeminal Nerve Stimulation (eTNS)
  • Vagus (Vagal) Nerve Stimulation (VNS)

Transcranial Magnetic Stimulation (TMS)

What is TMS?

Transcranial Magnetic Stimulation involves the use of magnetic pulses delivered to the brain via a device which does not touch the skin or scalp. The magnetic pulses cause tiny electrical currents in the brain tissue which modify and excite neurons. According to eNeura “This process is thought to interrupt the abnormal electrical activity associated with migraine and cortical spreading depression (CSD)”.

TMS Device

‘eNeura’ is one of the companies that supplies a TMS device. It is currently available in the US and UK. Their ‘Spring TMS’ device is small, portable and delivers a mild and brief pulse of magnetic energy to the back of the head. If the first pulse fails, it can be used again, with only a short interval between pulses (for the device to recharge). It is quick and easy to use. It is only available on prescription, and currently only from the UK or US. For more on how it works and how to go about getting a prescription, go to the eNeura website They have a video with instructions on its use. For information on how to get one of these devices, see the following PDF

MAI recently spoke to a representative from eNeura and are hopeful that this device will soon be available in Ireland. At the moment, Irish patients can be prescribed its use but only if they are referred to places such as King’s College London where Professor Peter Goadsby and his colleagues currently prescribe the device.

When the doctor sends your prescription (on a form filled out by both you and them) they send it to eNeura who send you the device along with an SD card or SIM card which has your individual programme on it. When you get the device you insert the card into the device and turn it on. There is a nurse advice line available for training and help (which you must go through), then you can get zapping!

Are there Side-effects?

Like all migraine treatments, there is an element of risk from side-effects with TMS. Generally TMS is well tolerated and little or no side-effects are reported. However, at the moment there is no data about the long-term effects of TMS. Immediate side effects may include minor vertigo or dizziness, nausea, slight pain at the sight of the pulse, tingling.

There are a lot of factors to consider when thinking about using a TMS device. eNeura have a list of warnings, precautions and contraindications that come with their ‘Spring TMS device. These are not to put people off just to make them fully aware of and comply with the safe use of the system.

Warnings about when not to use the device include but are not limited to;

  • Near flammable gases or petrol
  • When it’s wet, or near water
  • During the Aura phase of your attack, use when the pain hits
  • It doesn’t work on Cluster Headache

Precautions to keep the device at least 2 feet away from certain objects when it’s on include but are not limited to;

  • Mobile phones
  • Wireless network routers
  • Cordless telephones and their bases
  • Credit Cards
  • Computer
  • Flash memory sticks
  • MP3 players
  • Digital cameras
  • Glasses
  • Keys
  • Coins
  • Jewellery
  • Watches

Contraindications include but are not limited to having any or all of the following implants;

  • Pacemaker
  • Implanted Vagus Stimulator
  • Aneurysm clips or coils
  • Cochlear Implants
  • Stents
  • Filters
  • Any implanted medical device with metals of conductive materials

You can continue to use your normal migraine medications while using the TMS device but you should regularly consult with your doctor.

How much does it cost and how do I get it?

The TMS device is prescription only and cannot be bought, but can be rented from eNeura in the UK for;

  • 3 months @ £499 Sterling
  • 6 months @ £900 Sterling
  • 1 Year @ £1,611.60 Sterling

After you and your doctor fill out the necessary forms, you need to fill out a rental agreement form. You send it all off and as I mentioned above, eNeura will send you the device along with an SD card or SIM card which has your personal treatment plan on it.

You must always discuss it with your doctor when embarking on a new treatment plan.

 

Transcutaneous Electrical Nerve Stimulation (TENs)

What is TENs?

Aside from being difficult to say, Transcutaneous Electrical Nerve Stimulation more or less does what it says on the tin. Transcutaneous means literally ‘through the skin’ and it delivers mild electrical pulses through the skin via electrodes that are inside adhesive gel pads. These pads are stuck to the skin in the area required and the device is then used to the individual specifications of the sufferer. According to ‘Patterson Medical’ a company that makes TENs machine “TENs works by a method called pain gating where the stimulation of the TENs machine blocks the messages to the brain telling it the body is experiencing pain. It also encourages the brain to produce the body’s own natural painkilling hormones known as endorphins.”

TENs Device

There are hundreds of different kinds of TENs machines, some are as small as, or even smaller than a mobile phone, others look more like Mr. Spock’s Tricorder from ‘Star Trek®’, but each one acts in much the same way. For the sake of this ezine I’ve chosen the Patterson Medical TPN200 PLUS to look more closely at.

To get the best results, the electrodes should be placed over the area of pain and then treated for 30 – 60 minutes, depending on the area and tolerance. Many of the TENs machines can be programmed with different frequencies, different treatment options and some include a relaxation programme and some can target specific acupressure or acupuncture points on the body. Most come with a belt or lanyard so you can move around while being treated.

The TPN 200 Plus is available in Ireland and you can be ordered over the net. Again, caution must be used and you should consult your GP or Neurologist before using such a device.

Are There Side-effects?

Again the Precautions include but are not limited to;

  • Patients with an implanted electronic device (for example, a pacemaker) should not undergo TENs treatment without first consulting a doctor. The same applies to patients with any metallic implants.
  • If TENs therapy becomes ineffective or unpleasant, stimulation should be discontinued until its use is re-evaluated by the physician or therapist.
  • Avoid adjusting controls while operating machinery or vehicles.
  • Turn the TENs off before applying or removing electrodes.
  • Do not use it in the presence of explosive atmosphere and flammable mixture.

The warnings include but are not limited to;

  • Caution should be used in applying TENs to patients suspected of having heart disease. Further clinical data is needed to show there are no adverse results.
  • Electrical stimulation safety has not been established during pregnancy.
  • Do not use TENs during pregnancy.
  • Do not place electrodes on the front of the throat as spasm of the Laryngeal and Pharyngeal muscle may occur
  • Do not stimulate over the carotid nerve,
  • Cases of skin irritation at the electrode site have been reported.
  • Electrodes should not be placed over the eyes, in the mouth, or internally.

You can continue to use your normal migraine medications during use of the TENs machine but you should regularly consult with your doctor.

How much does it cost and how do I get it?

TENs devices cost different amounts of money and can be reasonably priced or very expensive. It depends on what you want. You can go to some pharmacies and buy the directly from them or you can order others on the internet. It’s basically up to you to decide what you need. Just remember that with a TENs device, you will at some stage need to buy replacement pads and these come with their own price tags.

Assist Ireland have a list on their website of various available TENS Devices

Remember to always discuss it with your doctor when embarking on a new treatment plan.

 

External Trigeminal Nerve Stimulation

What is eTNS?

External Trigeminal Nerve Stimulation (eTNS) involves administering precise micro-pulses of electricity to the Trigeminal Nerve. The trigeminal nerve is responsible for feelings and sensations in the face and is the largest of the cranial nerves (nerves that extend directly from the brain). It’s thought to be one of the most common factors involved in the pain of migraine. It’s made up of three branches: the ophthalmic (area around the eyes), maxillary ( area around the nose), and mandibular ( area around the jaw) nerves. According to Cefaly who make the Cefaly eTNS Device – “Neurostimulation of the trigeminal nerve with Cefaly produces a sedative effect. Regular repetition of this sedative effect helps reduce the number of attacks of migraine.”

eTNS Device

There are a few eTNS devices, but the one MAI has seen most of is the Cefaly device. This device uses an electrode which is positioned and stuck to the forehead. The Cefaly device itself connects to the electrode and “generates precise micro-impulses in order to stimulate the nerve endings of the trigeminal nerve” The electrode can be used up to 20 times. The Cefaly device is promoted as a preventative device not an abortive one so you use it every day to try to reduce frequency and severity. A typical session takes about 20 minutes and this would be one session every day. The intensity can be adjusted so that you are comfortable with the level of the pulses.

It has a setting for ‘Crisis Treatment’ so you can use it to help during an attack, but it also has an ‘Anti-stress’ setting which you can use to relax you between preventative sessions.

The Cefaly device can be bought via the Cefaly website, along with the electrodes. It doesn’t require a prescription for use, however, as it uses electrical energy, you should still consult with your doctor before using the device as it too is contraindicated in certain circumstances.

Are there Side-effects?

According to Cefaly, the sensation when using the device is strange and unusual, but most people get used to it after a few sessions. However some people are more sensitive and may find the sensation produced by the Cefaly painful. In this case you can try to lower the intensity to a more comfortable level which might help. If you find that you can’t use it, then stop straight away and return it to Cefaly or contact them through the numbers on their website. If you need to return it, you must make sure it’s in perfect condition and with its original packing within 14 days for a refund on the price. Cefaly has been passed as safe for use during pregnancy, but again a doctor’s supervision is recommended.

It comes with the following warnings and contraindications; Do not use the Cefaly device if;

  • you have an implanted metallic or electronic device in the head
  • you suffer from pain of unknown origin
  • you have a cardiac pacemaker or implanted or wearable defibrillator. This may cause interference with pacing, electric shock, or death
  • You can continue to use your normal migraine medications during use of the eTNS device but you should regularly consult with your doctor.

How much does it cost and how do I get it?

The Cefaly device can be bought over the Cefaly website via this link. It currently costs €295 for the device and between €19 and €24 the electrodes depending on which ones you choose. Again, there is no need for a prescription but…

Always discuss it with your doctor when embarking on a new treatment plan.

 

Vagus (Vagal) Nerve Stimulation (VNS)

What is VNS?

VNS is the use of electric currents to stimulate the vagus nerve. This nerve is the longest and most connected nerve in the body which starts at the brain stem and ends near your bowels. Electrical stimulation of the vagus nerve has been going on for years, used for disorders such as depression and epilepsy. The electrical impulses from a VNS device are applied through either electrodes implanted beneath the skin, or without implants via the direct contact with the skin. Electrocore, the makers of the gammaCore device say “It is not certain how vagus nerve stimulation treats and prevents migraines and cluster headaches, but data suggest that it may work by sending signals into the brain that reduce the amount of a chemical called glutamate, that has been associated with headache symptoms.”

VNS Device

The gammaCore device is the first of its kind; a hand-held device about the size of a mobile phone that generates a unique electrical signal which targets the vagus nerve. It’s non-invasive  –  so no implants needed and can be used to treat migraine, cluster headache and other headache disorders. A conductive gel is applied to the two ‘stimulation surfaces’ of the device and it’s placed on the neck. Each dose takes approximately 2 minutes

See the video below from the gammaCore website for more information on this device.
https://youtu.be/TZsXg0fr_fg

Are there Side-effects?

So far any side-effects noted are mild, and usually stop when treatment is finished.

The precautions include but are not limited to;

  • Hoarseness
  • Shortness of breath
  • Change in voice
  • Tingling/pricking feeling where the device is applied
  • The warnings include but are not limited to; – do not use if you have
  • A pacemaker,
  • Hearing aid implant,
  • Any implanted electronic device.
  • Been diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Had surgery to cut the vagus nerve in your neck.

How much does it cost and how do I get it?

The gammaCore device can only be got by applying through your doctor. It will require your GP to fill out an authorisation form and send it off to gammaCore. They will send the device either to your home or your doctor’s clinic. Both you and your doctor can avail of the training portal so that both of you can ensure you use the device most effectively. You buy a certain amount of doses at a time, either 150 doses or 300 doses. When you are finished all your doses, you must get a new device and dispose of the old one. Prices may have changed but last known prices were;

  • 150 doses £250 Sterling
  • 300 doses £500 Sterling

Always discuss it with your doctor when embarking on new treatment plan.