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

Официальное название

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

Обзор

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.

Подробное описание

External trigeminal nerve stimulation (eTNS) is a non-invasive technique involving external cutaneous stimulation of the trigeminal nerve. In 2019, the Monarch eTNS device was approved as a treatment for children with attention-deficit/hyperactivity disorder (ADHD). The Monarch eTNS device is designed to be applied at home, which offers a certain level of convenience but also necessitates a high degree of compliance and acceptability from the families.

The objective of the present trial is to assess the feasibility of and pilot a larger randomized clinical trial investigating the Monarch eTNS device versus sham for patients aged 7 to 17 years with ADHD.

The investigators will conduct a parallel-group, sham-controlled, feasibility randomised clinical trial. The investigators will include 60 children and adolescents (age 7 to 17 years) diagnosed with ADHD from three clinical sites in Denmark. Patients will be randomised to 4 weeks of active versus sham eTNS. Feasibility outcomes include completion of the trial; the number of eligible participants; treatment compliance and completion. Adverse events will be monitored throughout the trial. Exploratory clinical outcomes include ADHD core symptoms (primary) and several secondary outcomes. Autonomic functions will be evaluated by means of heart rate variability, using a heart rate sensor.

This trial will evaluate the feasibility of conducting a larger randomised clinical trial investigating the use of eTNS as a home-based, non-pharmacological intervention for children and adolescents diagnosed with ADHD.

Вмешательства

• Устройство 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
• Устройство 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 sensa

Первичные конечные точки

• The proportion of participants assessed for eligibility who consent to inclusion and randomization [Срок оценки: Four weeks]
• Compliance with the intervention [Срок оценки: Four weeks]
• Acceptability of the intervention [Срок оценки: Four weeks]
• Completion of follow up [Срок оценки: Four weeks]
• Use of concomitant treatment [Срок оценки: Four weeks]
• Safety and adverse events [Срок оценки: Four weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand — Slagelse

Публикации

• Edemann-Callesen H, Huus CL, Karstoft C, Bjarnadottir E, Bikic A, Jeppesen P, Martinsen OG, Pettersen FJ, Lindschou J, Juul S, Quistgaard M, Gluud C, Storebo OJ. 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. Eur Child Adoles PMID 40518459

Идентификаторы

NCT: NCT06655610 · 2401733

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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