The investigators will assess the use of the Monarch eTNS device as a non-pharmacological treatment for patients aged 7 to 17 years with ADHD.
The investigators will compare the eTNS device to a sham device. Participants will use the device for four weeks during night time. During the trial, participants will receive different questionaires to assess symptoms and will also keep a logbook to record their experience with the device.
At the end of trial, the investigators will assess what the families thought of the device, and whether it is indeed feasible to further explore the effect of the device in a larger clinical trial.
7 to 17 years of age at the time of study enrollment.
A clinical diagnosis of ADHD according to criteria for ICD-10: F90.0, F91.0, F90.8, F90.9, F98.8C. The ADHD diagnosis must be verified by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) using The Schedule for Affective Disorders and Schizophrenia for School-aged Children (K-SADS).
A score above 24 on the ADHD rating scale (ADHD-RS) at baseline.
Signed informed consent from parents/legal caretakers and from the patients aged ≥ 15.
Patients receiving atomoxetine and guanfacine at the time of study enrollment will be excluded all together
Epilepsy
Electronic or metallic implants.
Pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9)
Parallel
External Trigeminal Nerve Stimulation
DeviceActive eTNS will be provided by applying single, bipolar pulses of 0.5 milliseconds duration at a frequency of 125 hertz, with an active period of 30 seconds on/off. Stimulation current will range from 0.2 mili ampere (mA) to 10 mA. The level of current, which is noticeable, yet within the level of comfort, will be identified for each patient by titration at baseline. Depending on the perception of stimulation, the level of current may be altered during the four weeks of treatment, by either the guardian or adolescent in control of the settings.
Sham device
DeviceThe stimulator and patches will be identical in appearance to the active treatment. The guardian/the adolescent will be informed to administer the device in the same fashion as with active treatment. The sham device will however be programmed to only apply stimulation for 30 seconds every hour during sleep, optimally at a frequency of maximum 2 Hz. As with the active eTNS, the sham stimulation current will range from 0.2 to 10 mA. Such settings have previously been considered to induce the sensation of a current applied to the forehead as seen with active treatment, yet without it being therapeutically effective. Stimulation will be directed through an internal resister, which ensures draining of batteries and need for recharging after each session. The manufacture of the eTNS device (Neurosigma) will oversee the programming the sham device.
The proportion of participants assessed for eligibility who consent to inclusion and randomization
The investigators will compare the number of eligible participants to the number of randomized participants. We will accept a difference above 50 % (95 % CI 40.2 % to 59.6 %). A larger difference can impose difficulties with recruitment in a future randomized trial.
Compliance with the intervention
The investigators will calculate the number of participants fulfilling treatment. Compliance with treatment will be defined as completing the treatment in 70 % (95 % CI 57 % to 80 %) of the nights during the four weeks. Abruption of treatment can only be accepted if it happens within less than four nights in a row.
Acceptability of the intervention
The acceptability of the intervention will be assessed using a semi-structured qualitative interview guide with predefined questions: * How did you feel about administering and controlling the device? * How did your child feel about receiving this type of treatment? * How was it for your child to receive home-treatment with the device in addition to other strategies provided by the clinic? * Did the intervention have any influence on the relationship between your child and the parents/siblings/school/friends?
Completion of follow up
Completion of follow-up will be defined as completing the assessment of the primary exploratory clinical outcome at the end of the intervention. The number of participants with completed outcomes will be compared to the number of participants in total. If the number of participants completing this assessment is above 90 % (95 % CI 92 % to 97 %), this will be acceptable for a future full-size trial. If the number of participants completing the assessment is below 75 %, this will introduce serious problems with the interpretation of the results.
ADHD core symptoms
Exploratory outcome. Measured by the ADHD-IV rating scale (parent- and teacher rated) (31). Assessed at baseline, weekly, and at end of treatment
Absence from school
Exploratory outcome. Measured as total hours of absence reported by logbook (parents) and through direct contact with the teachers.
Emotional liability
Exploratory outcome. Measured by Conners 3 Global index, Emotional liability subscale (parent - and teacher rated)
General behavior
Exploratory outcome. Measured by the Child Behavior Checklist (CBCL) (parent - and teacher rated)
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Psychiatric Research Unit, Region Zealand, Denmark
Lead sponsor
University of Southern Denmark
Sponsor institution
