How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Description of the procedure

    Indications and current treatment

    Attention deficit hyperactivity disorder (ADHD) is a heterogeneous disorder characterised by the core symptoms of hyperactivity, impulsivity and inattention, which are judged excessive for the person's age or level of overall development. Symptoms are usually evident in childhood and may persist into adulthood.

    Treatment for ADHD may be non-pharmacological, pharmacological, or a combination of both. Non-pharmacological treatment includes cognitive behavioural therapy and parent-training programmes (for parents of children and young people with ADHD). Pharmacological treatment includes central nervous system stimulants such as methylphenidate and amphetamines.

    What the procedure involves

    In this procedure, an external trigeminal nerve stimulation (TNS) device is worn on the clothes and attached by wires to a single-use adhesive patch which is worn overnight. The patch contains 2 electrodes placed over the left and right V1 branches of the trigeminal nerve on the forehead. The stimulator bilaterally stimulates the trigeminal nerve for approximately 8 hours. For children, parents or carers attach the device. Treatment duration may vary – a clinical response may take several weeks, and continued therapy may be needed.

    The mechanism of action is not completely understood. The trigeminal nerve connects to regions of the brain that may be associated with selective maintenance of attention, and it is thought that its stimulation improves the symptoms of ADHD.

    Outcome measures

    ADHD-specific symptom and behavioural measures

    ADHD-RS

    The ADHD-IV Rating Scale (ADHD-RS) is an 18-item questionnaire that measures the severity of ADHD symptoms. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Higher scores indicate worse symptoms.

    Conners Global Index

    The Conners Global Index is a 10-item questionnaire that assesses the severity of common ADHD symptoms.

    Other symptom and behavioural measures

    ARI

    The Affective Reactivity Index (ARI) is a 7-item questionnaire that assesses irritability across 3 aspects: threshold for an angry reaction; frequency of angry feelings/behaviours; and duration of such feelings/behaviours.

    CBCL

    The Child Behaviour Checklist (CBCL) is a questionnaire used to assess emotional, behavioural, and social problems. The CBCL contains items across 8 categories: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, and aggressive behaviour.

    CDI

    The Children's Depression Inventory (CDI) is a 27-item questionnaire that assesses the presence and severity of depression. Each item consists of three statements graded in order of increasing severity from 0 to 2. A higher CDI score means a higher depressive state.

    CDRS

    The Children's Depression Rating Scale (CDRS) is a 17-item scale that assesses the severity of depression and change in depressive symptoms. Items range from 1 to 5 or 1 to 7. A score of 40 or more is indicative of depression, whereas a score of 28 or less is often used to define remission.

    CGI
    CGI-I

    The Clinical Global Impressions-Improvement (CGI-I) is a 1-item questionnaire that allows clinicians to compare the patient's overall clinical condition to baseline. The rating ranges from 1: 'very much improved since the initiation of treatment', to 7: 'very much worse since the initiation of treatment'.

    CGI-S

    The Clinical Global Impressions-Severity (CGI-S) is a 1-item questionnaire that allows clinicians to rate the severity of illness. The rating ranges from 1: 'normal' to 7: 'Extremely ill'.

    CSHQ

    The Children's Sleep Habits Questionnaire (CSHQ) is a 45-item questionnaire that assesses sleep behaviour in children. The CSHQ contains 8 subscales: Bedtime Resistance, Sleep Onset Delay, Sleep Duration, Sleep Anxiety, Night Wakings, Parasomnias, Sleep-Disordered Breathing, Daytime Sleepiness.

    C-SSRS

    The Columbia–Suicide Severity Rating Scale (C-SSRS) is a questionnaire that assesses the severity of suicidal ideation and suicidal behaviour. The C-SSRS contains items across the following domains: severity of ideation, intensity of ideation, behaviour, and lethality.

    MASC

    The Multidimensional Anxiety Scale for Children (MASC) is a 39-item questionnaire that assesses the presence of symptoms related to anxiety disorders. The MASC consists of 4 subscales: physical symptoms, social anxiety, harm avoidance, and separation anxiety.

    Cognitive functioning measures

    ANT

    The Attention Network Test (ANT) is a task designed to test 3 attentional networks: alerting, orienting, and executive control.

    BRIEF

    The Behavioural Rating Inventory of Executive Functioning (BRIEF) is an 86-item questionnaire that assesses impairment of executive function. The BRIEF includes items on behavioural regulation ('inhibit' – control impulses, 'shift' – move from 1 activity to another, and 'emotional control') and meta-cognition ('initiate' – begin activity, 'working memory', 'planning and organisation', and 'monitor' – assess own performance).

    Flanker test

    The Flanker test is a test of response inhibition that assesses ability to suppress incorrect responses in a particular context.

    SWM

    The Spatial Working Memory (SWM) assesses retention and manipulation of visuospatial memory.

    WISC-4

    The Wechsler Intelligence Scale for Children (WISC-4) is an IQ test for children. Subtests include the Digit Span subtest, where children are asked to repeat increasingly long strings of numbers forward and backwards in the same order as presented aloud by an examiner.

    WRAT

    The Wide Range Achievement Test (WRAT) assess reading, comprehension, spelling, and mathematics abilities.