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Prof Katya Rubia
+44 (0)7780611801
katya.rubia@kcl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Effects of external trigeminal nerve stimulation in ADHD and mechanisms of action
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Effects of external trigeminal nerve stimulation in ADHD and mechanisms of action

Not Recruiting

Open to: All Genders

Age: Child

London Southampton

Medical Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Attention Deficit Hyperactivity Disorder (ADHD) affects 7% of children worldwide; it consists of problems with poor attention, impulsivity, and hyperactivity. Most have problems in adulthood where ADHD is associated with poor social and employment outcomes. Children with ADHD also struggle with cognitive (thinking) skills (e.g., attention) and self-control. Treatment is with stimulant medication. However, this has side effects, does not work for everyone, and has limited longer-term effects. Non-drug treatments with fewer side effects would be preferred but most have shown little effects.
The first non-drug ADHD treatment device was approved in 2019 by the USA Food and Drug Administration (FDA), called external trigeminal nerve stimulation (eTNS). eTNS is a battery charged device that sends small electrical pulses or currents under the skin on the forehead and can be applied during sleep. eTNS activates the trigeminal nerve on the forehead which leads to the activation of the brain stem and frontal brain regions that are important for arousal and attention.
A pilot study in 62 children with ADHD showed an improvement of ADHD symptoms after 4 weeks of eTNS compared to placebo eTNS (fake, with no electrical currents) after it was used every night with children by their parents for 4 weeks, with minimal side effects. An earlier smaller study with 22 ADHD children showed that eTNS improved ADHD behaviours and cognitive abilities (e.g., inattention).
The aim of this study is to further confirm in a large group of 150 children and adolescents with ADHD whether eTNS improves ADHD symptoms, whether it improves academic abilities (e.g., attention), whether the effects are still observed 6 months later and how it works on the brain. The study is important as it will establish whether eTNS is an effective non-drug treatment for ADHD with minimal side effects that can be administered at home and would therefore be preferred by patients, parents, and clinicians. Such a treatment would improve healthcare and reduce the strain of the disease for patients.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2022 19 Nov 2024

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38689273/ (added 14/05/2024)

Participants are randomly allocated to eTNS or placebo eTNS treatment (with no electrical currents) to test whether eTNS is better than placebo eTNS at improving parent and teacher-rated ADHD symptoms and cognitive performance in tests of self-control and attention. The treatment involves using the TNS device while the child is sleeping for 7-9 hours per night for 4 weeks; this is a disposable patch with a battery that can be attached to their pyjamas or placed under their pillow. It is not painful and has minimal side effects.
Participation in the study involves an assessment of the behaviour and cognitive functions of the child at the start of the study, after the treatment and at follow up. It will require four visits to the research centers and several online appointments. The researchers will also measure safety, pupil response and activity and heart rate and heart rate variability using a wrist-worn device at each centre visit.
The researchers also want to understand how eTNS works in the brain. Therefore, they will use functional magnetic resonance imaging (fMRI) to test the effects of eTNS on the brain function of ADHD children in a subgroup of 56 patients. Furthermore, they will test whether eTNS has side effects and whether effects continue 6 months after treatment.


Children aged 8-18 years with a clinical diagnosis of ADHD

You can take part if:


Current inclusion criteria as of 12/08/2022:
1. Children and adolescents, aged 8-18 years at study entry
2. ADHD diagnosis (DSM-5; based on the K-SADS)
3. A score higher than 24 on the investigator-scored parent-rated ADHD-RS (DSM-5) (to include participants who still have relatively high symptoms)
4. Scoring above the clinical cut-off for ADHD (5 or above) on the combined summary score of the child and parent ratings Kiddie Schedule for Affective Disorders and Schizophrenia, for School-age Children- present and lifetime version, ADHD module (K-SADS) (Kaufman et al., 1996)
5. Both parent and child need to speak English (defined as sufficient to complete study assessments)
6. IQ above 70 as assessed on the Wechsler Abbreviated Scale of Intelligence (WASI-II) (Wechsler, 1999) (to exclude participants with a learning disability)
7. Patients should be either medication-naïve OR willing to come off their stimulant medication for one week before the trial OR willing to be on stable medication for the dur


You may not be able to take part if:


Current exclusion criteria as of 12/08/2022:1. Comorbidity with any other major psychiatric disorder (except conduct/oppositional defiant disorder, mild anxiety and depression- as assessed on the K-SADS, as these are commonly associated with ADHD)2. Alcohol and/ or substance abuse (as assessed on the K-SADS) (potential confound)3. Neurological abnormalities, such as epilepsy (potential confound)4. Current medication with atomoxetine or guanfacine or in the past two weeks (as these have an effect on the arousal system to be improved with eTNS)5. Participants who usually take drug holidays on weekends or holidays will not be able to participate in the study unless they are willing to take their stimulant medication in a stable way throughout the study or not at all throughout the study and 1 week before the study (Participants will be either on medication or off medication to decrease heterogeneity).6. Implanted cardiac or neurostimulation systems (contraindication to eTNS)7. Implanted metallic or electronic device in their head (contraindication to eTNS)8. Presence of body-worn devices (e.g., insulin pumps and t-VNS) (contraindication to eTNS)9. Currently receiving any non-medical treatment (e.g., psychotherapy, counselling, parent-training, cognitive rehabilitation, EEG neurofeedback) (potential confound)10. Participants with dermatitis (could be sensitive to patches)11. Traumatic Brain Injury (TBI) (potential confound)

Additional exclusion criteria for the 56 patients that will participate in the fMRI study12. Under 10 years old13. Have any MRI contra-indications (e.g., metal implants, pacemakers, braces, tattoos/piercings claustrophobia etc.) which would render them unsuitable for the fMRI sub-study14. Be pregnant and/or breastfeeding if female

If patients are COVID positive, the participant’s involvement in the trial will be delayed. If any patient develops COVID during the trial, arrangements will be made as required for the individual case. Previous exclusion criteria:1. Comorbidity with any other major psychiatric disorder (except conduct/oppositional defiant disorder (see above), mild anxiety and depression (as assessed on the K-SADS)2. Alcohol and substance abuse (as assessed on the K-SADS)3. Neurological abnormalities, such as epilepsy. 4. Medication with atomoxetine or guanfacine.5. Implanted cardiac or neurostimulation systems (contraindication to TNS)6. Implanted metallic or electronic device in their head (contraindication to TNS)7. Presence of body-worn devices (e.g., insulin pumps and t-VNS) (contraindication to TNS)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • King's College London
    Department of Child Psychiatry/SGDP PO46 Institute of Psychiatry, Psychology & Neuroscience De Crespigny Park
    London
    SE5 8AF
  • Southampton University
    Centre for Innovation in Mental Health (CIMH), School of Psychology Highfield Campus, Building 44, Room 4059, University Rd
    Southampton
    SO17 1PS

It is very likely that the behaviour of the patients will improve with the TNS treatment if they are in the active group. Also, it is hoped that the information collected will establish whether TNS is a suitable treatment for ADHD and therefore help treat other young people with ADHD with TNS in the future. However, the researchers cannot guarantee that every patient gets better as this is a research study and there is no guarantee that every child gets better with the TNS treatment. In addition, the patient will also get some information about their intellectual performance which could be useful for school planning, and information about their clinical profile (i.e. the results of the questionnaires which will be an indicator of the severity of the patient’s symptoms). It could potentially be a bit uncomfortable to sleep with the TNS device at night. However, in a previous study the sleep patterns of the children became better and not worse.
No serious side effects or adverse events have been reported in studies with TNS and the researchers do not expect any side effects. However, they cannot guarantee that the patients will not have any side effects and some have complaints about headache (that quickly goes away) or skin irritation (that goes away with cream).

Prof Katya Rubia
+44 (0)7780611801
katya.rubia@kcl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by King's College London; South London and Maudsley NHS Foundation Trust and funded by National Institute for Health Research; Medical Research Council.



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Read full details for Trial ID: ISRCTN82129325

Or CPMS 49887

Last updated 26 November 2024

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