RECRUITINGINTERVENTIONAL

External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial

External Trigeminal Nerve Stimulation Versus Sham Stimulation for Attention Deficit Hyperactivity Disorder in Children and Adolescents Aged 7-17 Years: Study Protocol for a Pilot and Feasibility Randomized Clinical Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form from parents/legal caretakers and from the patients aged ≥ 15. We will include treatment-naïve patients, patients who previously have received stimulant medication, and patients in stable, ongoing stimulant medication (methylphenidate or dexamphetamines/lisdexamphetamine) during the time of the trial. Who Should NOT Join This Trial: - Patients receiving atomoxetine and guanfacine at the time of study enrollment will be excluded all together - Epilepsy - Electronic or metallic implants. - Serious mental and/or somatic diseases other than ADHD, such as: - Pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9) - Schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29) - Mania or bipolar disorder (ICD-10 F30 and F31) - Depressive psychotic disorders (ICD-10 F32.3 + F33.3) - Substance dependence syndrome (ICD-10 F1x.2) - Cardio-vascular disorders - Cancer - An Intelligence quotient (IQ) below 70 measured by the Wechsler Intelligence Scale for Children - A substantial degree of restless sleep as reported by parents or caregivers and evaluated by the physician. - Other disabilities that may make use of Monarch problematic. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. We will include treatment-naïve patients, patients who previously have received stimulant medication, and patients in stable, ongoing stimulant medication (methylphenidate or dexamphetamines/lisdexamphetamine) during the time of the trial. Exclusion Criteria: * Patients receiving atomoxetine and guanfacine at the time of study enrollment will be excluded all together * Epilepsy * Electronic or metallic implants. * Serious mental and/or somatic diseases other than ADHD, such as: * Pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9) * Schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29) * Mania or bipolar disorder (ICD-10 F30 and F31) * Depressive psychotic disorders (ICD-10 F32.3 + F33.3) * Substance dependence syndrome (ICD-10 F1x.2) * Cardio-vascular disorders * Cancer * An Intelligence quotient (IQ) below 70 measured by the Wechsler Intelligence Scale for Children * A substantial degree of restless sleep as reported by parents or caregivers and evaluated by the physician. * Other disabilities that may make use of Monarch problematic.

Treatments Being Tested

DEVICE

External Trigeminal Nerve Stimulation

Active 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.

DEVICE

Sham device

The 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.

Locations (1)

Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark

Slagelse, Region Sjælland, Denmark