Clinical trial NCT06655610: External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD - Attention Deficit Disorder with Hyperactivity
Keywords: ADHD
Neuromodulation
External trigeminal nerve stimulation
feasibility trial
Lead sponsor: Psychiatric Research Unit, Region Zealand, Denmark
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of participants assessed for eligibility who consent to inclusion and randomization
timeFrame: Four weeks
measure: Compliance with the intervention
timeFrame: Four weeks
measure: Acceptability of the intervention
timeFrame: Four weeks
measure: Completion of follow up
timeFrame: Four weeks
measure: Use of concomitant treatment
timeFrame: Four weeks
measure: Safety and adverse events
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
measure: ADHD core symptoms
timeFrame: Four weeks
measure: Absence from school
timeFrame: Four weeks
measure: Emotional liability
timeFrame: Four weeks
measure: General behavior
timeFrame: Four weeks
measure: Quality adjusted life years
timeFrame: Four weeks
measure: Functional impairment
timeFrame: Four weeks
measure: Overall severity and improvement in symptoms
timeFrame: Four weeks
measure: Behavioral and emotional difficulties
timeFrame: Four weeks
measure: Cognitive functioning
timeFrame: Four weeks
measure: Sleep quality
timeFrame: Four weeks
measure: Autonomic functions
timeFrame: 4 weeks
Locations:
city: Slagelse
country: Denmark
facility: Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
state: Region Zealand
Study officials:
affiliation: Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
name: Ole Jakob Storebø, Professor
role: PRINCIPAL_INVESTIGATOR
References: