External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
- Conditions
- ADHD - Attention Deficit Disorder with Hyperactivity
- Registration Number
- NCT06655610
- Lead Sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
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Patients receiving atomoxetine and guanfacine at the time of study enrollment will be excluded all together
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Epilepsy
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Electronic or metallic implants.
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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
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An Intelligence quotient (IQ) below 70 measured by the Wechsler Intelligence Scale for Children
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A substantial degree of restless sleep as reported by parents or caregivers and evaluated by the physician.
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Other disabilities that may make use of Monarch problematic.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The proportion of participants assessed for eligibility who consent to inclusion and randomization Four weeks 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 Four weeks 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 Four weeks 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 Four weeks 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.
Use of concomitant treatment Four weeks Any concomitant treatment or changes in medication will be assessed for each participant and subsequently evaluated for the two groups at the end of the trial.
Safety and adverse events Four weeks Parents will be able to report directly to a dedicated investigators not involved in data analysis, with any concerns regarding potential adverse events or other safety issues during the trial. Adverse events will be measured by an adverse events rating scale at the end of treatment. Height, weight and vital signs will be assessed at baseline and again following the four weeks of treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
🇩🇰Slagelse, Region Zealand, Denmark