King’s College London – ADHD eTNS Collaboration

The aim of this study is to test a new treatment for children with ADHD (Attention Deficit Hyperactivity Disorder).

The best current treatment for children with ADHD is with stimulant medication. However, there can be side effects and the effect of long-term use of stimulant medication is unclear. This research is testing a new non-drug treatment, called external Trigeminal Nerve Stimulation (eTNS).

eTNS has been shown to work well in children with ADHD in a study in the USA, and it has no serious side effects. eTNS is worn during sleep and has been shown to be safe and effective for ADHD; it is the first device based non-drug treatment that has been approved for children with ADHD by the US Food and Drug administration (FDA) in 2019 so it is a relatively new treatment.

The purpose of the study is to test the eTNS treatment in a larger group of ADHD children and adolescents across two centres (London and Southampton). The study will establish whether eTNS is effective in reducing symptoms of ADHD and other problems such as mood, concentration, memory, and sleep. It will also establish whether it improves performance in attention and self-control. This will be done using computer tests. The questionnaires and computer tests will be done before using the device, after four weeks of using the eTNS device while sleeping and then again after 6 months to see whether the effects remain.

We expect that this research may lead to the establishment of a new non-drug treatment for ADHD which has minimal side effects. We expect that this treatment may improve the behavioural difficulties children with ADHD have and that it will also improve their attention and self-control skills. We also expect to see increases in brain activation in the brain regions like the frontal lobes, that are normally not working so well in children with ADHD.

If this study is successful, it could establish eTNS as a non-drug treatment for ADHD.

The eTNS device is an approved treatment for ADHD in the USA.

It is a non-invasive medical device that stimulates the trigeminal nerve using a small external electric patch, which resembles a large plaster/band-aid directly on the forehead. The nerve stimulates the brain and there is some indication that it increases the activity in the frontal lobes in people with ADHD.

Your child may be invited to participate because they have been diagnosed with ADHD, though your child’s doctor will first discuss this with you should they wish to propose this to you and your child.

You may also be invited to participate via parent support groups, your local GP or via social media. The trail organisers are seeking 150 children with ADHD between the ages of 8 and 18 to take part in the study.

No.

It is up to both you and your child whether to join the trial, if your child is eligible.

If you and your child do agree to take part, we would ask you to sign a consent form allowing your child to take part in the study. The researchers would also ask your child to assent to the trial too.

You would need to understand what the trial involves and what it would mean for your child before you can consent and the King’s College London researchers would go through this, with you. Identifiable data already collected with consent would be retained and used in their study. No further data would be collected, or any other research procedures carried out.

You or your child can still change your mind at any time, and you do not have to say why.

If you decide to change your mind, this will not affect your child’s treatment in any way. The King’s College London researchers’ would retain only the information collected up to that point.

There are a few reasons why your child may not be invited to participate in this study.

Your child may not be eligible if they:

• Have other mental health conditions. However, if your child has some conditions such as conduct disorder or oppositional defiant disorder or mild anxiety and depression, they are still eligible to participate
• Are taking non-stimulant medication such as Atomoxetine (Strattera) or Guanfacine
  (Intuniv, Tenex)
• Have any neurological conditions (like epilepsy)
• Suffer from alcohol or drug abuse
• Have any implanted devices (like cardiac devices) or presence of body worn devices (like
  insulin pump)

If you and your child do wish to participate we will provide further information on this topic directly to you.

If you decide to take part as a parent, we would ask you to:

• Be interviewed and asked some questions about your child’s symptoms and behaviour and
  also provide some background information and medical history. These will be similar questions to those that you had when your child was first assessed for ADHD. This can be done either virtually or face to face and be split into more than one session
• Complete some questionnaires about your child every week as well as a daily sleep diary for four weeks. This can be done virtually together with the researcher, or you could fill these in and send these to us
• During the first visit you will receive training on how to use the eTNS device and how to look
  after it
• At each visit, you will be asked some questions about your child’s behaviour and symptoms
• You will be asked for contact details of your child’s teacher to ask them to fill in some
  questionnaires about your child if they are happy to do so. You can still take part even if your
  child’s teacher does not want to fill in some questionnaires
• Provide us with contact details of your local GP and NHS prescriber so that they are aware that your child is participating in this project

If you wish your child to take part in this study, they would kindly be asked to:

• Be interviewed and asked to answer questions about their behaviour
• Have their IQ tested
• Use the eTNS device for four weeks
• For four weeks during the treatment, answer weekly questions virtually
• Wear a device on their wrist for 3-4 hours on some visits to the research centre- this is not
  expected to be too uncomfortable as it is very similar to a “fitbit”
• Come to the research centre four times to complete some cognitive tasks on the computer
  and answer some questions about their behaviour
• At the centre, they will have their height, weight and vital signs measured

The King’s College London researchers hope that the information they get will establish whether eTNS is a suitable non-drug treatment for ADHD and therefore help treat other young people with ADHD with eTNS in the future.

There is potential that your child’s behaviour improves with the eTNS treatment. However, we cannot guarantee that your child gets better as this is a research study and there is no guarantee that every child gets better with the eTNS treatment.

In addition, you will also get some information about:

1. your child’s intellectual performance which could be useful for school planning; and
2. about your child’s clinical profile i.e. the results of the questionnaires you’ll be asked to fill in as an indicator of the severity of your child’s ADHD symptoms

At the end of their study, the King’s College London researchers will send you and your child a letter about the results of the study if you are interested.

The doctor responsible for your child’s treatment has access to your child’s medical records and may refer you and your child to this research if they feel that your child may potentially benefit from participating. It its entirely up to you and your child whether or not you wish to participate though.

With your written permission, as part of the research, the King’s College London researchers may also request that their research team access the medical records for your child, but only if you consent and your child assents.

Yes.

Anything that the researchers find out about your child will be kept confidential. Any information that they have collected from your child or about your child will be saved in computer files but will be coded and have your child’s name removed so that no one can tell it is your child.

This applies to any data, including any behavioural questionnaires you have filled in, any cognitive performance data, any physiological data and any IQ data that your child has given the researchers. In the data system where the researchers will input all information about your child and which they use to analyse the data, will use your child’s initials and month and year of birth but nothing else that can identify your child.

Later this information will be removed and only a code number will be kept.

King’s College London and South London and Maudsley NHS Foundation Trust are the sponsor for this study. We will be using information from you and your medical records to undertake this study and will act as the data controller for this study. This information will include your name and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure. King’s College London will keep identifiable information about you for 3 years after the study has finished.

Once we have finished the study, we will keep some of the data so we can check the results. We will
write our reports in a way that no-one can work out that you took part in the study.

You can stop being part of the study at any time, without giving a reason.

If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

The results of this study will appear as articles in special magazines that medical doctors and scientists read.

If you would like to read the results you can have copies of these articles sent to you by asking the research team at King’s College. However, your name will not be in any of these articles, and we will only report the effects of the eTNS treatment on the group of ADHD children and not mention any individual people. In addition, we will also provide you with a summary of the research results in everyday (non clinical) language.

The Chief Investigator is a professor at King’s College’s Department of Child and Adolescent Psychiatry, Institute of Psychiatry.

This study is being funded by National Institute of Health Research and the Medical Research Council, both UK government funding agencies that fund research.

All research in the NHS is looked at by an independent group of people, called a Research Ethics
Committee, to protect your interests.

This study has been reviewed and granted a favourable opinion by the West Midlands – Solihull NHS Research Ethics Committee.

Please contact research@dr-giaroli.org with any questions you have, we will do our best to answer them, and we can signpost you to the research team directly at King’s College.