FAQ

No. We will ask you to put the device current to a current which is noticeable but which does not hurt you. So you will be in full control over the settings and what you can tolerate. If it is too painful you can at every moment turn the current down until it is no longer painful.

Are there any side effects of eTNS?

Most people have no side effects. Some people may experience some headache or skin irritation under the forehead where the patch is, but this goes away quite quickly.

Does eTNS improve my ADHD symptoms?

A study in the USA showed that it improved the behaviours of children with ADHD. So we believe it will improve your problems. However, you may end up in the placebo group, in which case you would not improve much.

How long do I have to use the eTNS device for?

We ask you to use it for 4 weeks if you want to participate in the trial.

How does the eTNS device work?

It is not entirely understood how the device works that is why we will do a brain scan before and after to see what it does to the function of the brain. It is thought that the stimulation of the trigeminal nerve on the forehead, stimulates the brainstem which then stimulates the brain systems of arousal and attention. Some studies have shown that eTNS activates attention areas in the brain that are affected in ADHD such as the frontal lobes and underlying structures. Also it is thought to enhance the neurotransmitters (chemicals in the brain) that are not optimal in ADHD in the same way as the ADHD medications.

How long do I have to wear the device every night?

We expect you to wear it during the whole time you go to bed, so about 8 hours or longer for 4 weeks.

Does wearing the eTNS device disturb my sleep?

The brain adapts and you will not notice the stimulation of the device after some time, because you will get used to it. Also, in the previous US trial, the children reported that they slept better with the device and were not disturbed in their sleep. This may be because their hyperactivity improved.

How old do I have to be to participate in the study?

You need to be between 8 and 18 years of age

Can I use the device and take medication for ADHD at the same time?

Yes, if you take stimulant medication such as Methylphenidate (Ritalin); Dexamfetamines (Dexedrine, Aderall) or Lisdexamfetamines (Vvanse). You can still take your stimulant medication as usual but we will ask you not to change the dose during the time you participate in the trial (4 weeks) and not to take any time off the medication on weekends or holidays while you are in the trial. You can also take the medication off for 2 weeks before and for the entire duration of the trial if you want to.

However, if you take non-stimulant medication like Atomoxetine (Strattera) or Guanfacine (Intuniv), then you cannot participate in the trial (because the device works similar to these drugs and then we would not be able to separate the effects of the device from the effects of the drugs).

Can I use the device and take other non-drug treatments at the same time?

No, because we want to see the effect of the device alone and not in a combination with other treatments. We will ask you to not take any other non-drug treatments like behavioural or psychological treatments, EEG-Neurofeedback, or any other treatments other than homeopathy, diets or supplements.

Can I use the device by myself or do my parents have to put it on me?

If you are old enough to do it yourself you could apply the device by yourself.

Will the eTNS device change how my brain works?

We think that indeed the eTNS will increase the activity in the frontal parts of the brain that are important for attention in ADHD children. The previous study in the USA showed that after 4 weeks of the eTNS treatment, there was an increase in the activity over right frontal parts of the brain that are crucial for self-control and attention.

If the device works for me, can I keep using it after the participation in the study?

Unfortunately currently the device is only licenced for use in the USA and Australia. However, this is likely to change in the next years and it will be licenced in the UK. This means you will be able to buy the device then (which currently costs about £700).

I have just pierced my ears/nose/bellybutton/etc and can't remove the jewellery. Can I still do the MRI scan?

Unfortunately you cannot have an MRI scan with any piercing or any metallic items in your body as it could be dangerous for you.

I have amalgam/fillings in my teeth, can I still do the MRI scan?

Yes metallic fillings in the teeth are not a problem and you can do the MRI scan.

Can my parents/carers be in the room when I have my MRI scan?

Yes your father/mother/carer can be in the MRI room if you want and hold your feet when you have the MRI scan.

I am having braces fitted soon, can I still take part?

Yes you can still take part.

During the visits to the research center, will my parents be always be in the room?

Yes they can be in the same room as you all the time except when we do an interview with you.

I am 16 years old, can I go to the research centre on my own because my parents are working?

Yes you can come to the center on your own. However, it is best if your parents come with you since we need to talk to them as well. However, if you live nearby and you are over 16 years old it would be ok to come here on your own but we would then have to arrange another time to talk to your parent.

How will I get paid?

We will ask your parent/carer to fill in an expense claim form with their bank details. If you are over 16 years old we will ask you to fill in the form with your bank details. After the first and second research visits you will receive £50 for each visit and after the third visit (after you have tried the device for 4 weeks) you will receive £200 and then after the fourth research visit (6 months after you have tried the device) you will get an additional £50. If you are also doing the optional fMRI part you will get an additional £50 per scan, in total £100.

I would like to drive to the research centre, is there anywhere to park?

Yes, we can arrange parking. Please contact the research team and we will try to find you a parking slot in our parking.

Can I get help with buying the train/bus tickets for coming to the research centre?

Yes we can book the tickets for you if you want and send the tickets to you.

What if I can't sleep with the TNS device, do I still have to use it?

You can call the support at any time and discuss with us whether there is anything we can do to make it more comfortable for you. If you really can't sleep or find the device very uncomfortable or if you have side effects that really bother you, you can stop using the device at any time.

Can I go on holidays while using the device?

In principle yes, but taking the device on a flight could be a problem, so it would be better to not go on a flight while you are using the device. You can talk to us and we can see whether this is possible. But you can go on holidays by train and car as long as you take the device with you.

What if I forget to use the device?

This is not a problem, just continue to use the device. If you tend to forget it more than once, please contact technical support and they will try to help you and find a way of reminding you to use the device.

I don't want my interview recorded, is that ok?

Yes this is ok, you can tell us and we will not record it if you prefer