NCT Number: NCT06655610
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.
Interested in participating?
Request Info7 year–17 year
All sexes
Interventional
Not applicable
Slagelse, Region Sjælland, 4200, Denmark
Location status: Recruiting
Henriette Edemann-Callesen, Phd, MD
CONTACT
Ole Jakob Storebø, Professor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Four weeks
The acceptability of the intervention will be assessed using a semi-structured qualitative interview guide with predefined questions:
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Four weeks
Exploratory outcome. Measured by the ADHD-IV rating scale (parent- and teacher rated) (31). Assessed at baseline, weekly, and at end of treatment
Time frame: Four weeks
Exploratory outcome. Measured as total hours of absence reported by logbook (parents) and through direct contact with the teachers.
Time frame: Four weeks
Exploratory outcome. Measured by Conners 3 Global index, Emotional liability subscale (parent - and teacher rated)
Time frame: Four weeks
Exploratory outcome. Measured by the Child Behavior Checklist (CBCL) (parent - and teacher rated)
Time frame: Four weeks
Exploratory outcome. Measured by the Child Health Utility instrument (CHU9D) (parent/self-rated)
Time frame: Four weeks
Exploratory outcome. Measured by the Weiss Functional Impairment Rating Scale (WFIRS) (parent/self-rated)
Time frame: Four weeks
Exploratory outcome. Measured by the Clinical Global Impressions Scale (CGI) (investigator-rated).
Time frame: Four weeks
Exploratory outcome. Measured by the Strengths and Difficulties Questionnaire (SDQ) (parent - and teacher rated)
Time frame: Four weeks
Exploratory outcome. Measured by the Behavior Ratings of Individual Executive Functions (BRIEF) (parent - and teacher rated)
Time frame: Four weeks
Exploratory outcome. Measured by The Children Sleep Habits Questionnaire (CSHQ) (parent - and teacher rated). Assessed at baseline, weekly and at end of treatment.
Time frame: 4 weeks
Evaluated by means of heart rate variability, using a heart rate sensor.
Contact information is provided by the study sponsor or research team.
Henriette Edemann-Callesen, Phd, MD
CONTACT
Ole Jakob Storebø, Professor
CONTACT
Psychiatric Research Unit, Region Zealand, Denmark
Other
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
Acronym: eTNS4ADHD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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