ADHD - Attention Deficit Disorder With HyperactivityeTNS4ADHDNCT06655610
External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
A study testing External Trigeminal Nerve Stimulation in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity
- What is being tested?
- External Trigeminal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Dec 2024to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
Slagelse, Region Sjælland, 4200
Ole Jakob Storebø, Professor, 0045 24965917, ojst@regionsjaelland.dk
Henriette Edemann-Callesen, Phd, MD, 0045 28343531, henriette.callesen@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- External Trigeminal Nerve Stimulation, Sham device
- Keywords
- ADHD, Neuromodulation, External trigeminal nerve stimulation, feasibility trial
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Trigeminal Nerve StimulationDevice
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.
Sham deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active eTNS | Experimental | Not described Receives: Device: External Trigeminal Nerve Stimulation |
| Sham eTNS | Sham comparator | Not described Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants assessed for eligibility who consent to inclusion and randomization
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.
Measured: Four weeks
Compliance with the intervention
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.
Measured: Four weeks
Acceptability of the intervention
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?
Measured: Four weeks
Completion of follow up
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.
Measured: Four weeks
Use of concomitant treatment
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.
Measured: Four weeks
Safety and adverse events
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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start5 Dec 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Jakob Storebø, University of Southern Denmark
- Investigators
- Ole Jakob Storebø, Professor, Principal investigator, Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655610
- Sponsor's protocol ID
- 2401733
- Acronym
- eTNS4ADHD
- Status last verified
- Mar 2026
- First submitted
- 4 Sep 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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 Adolesc Psychiatry. 2025 Dec;34(12):3833-3842. doi: 10.1007/s00787-025-02786-7. Epub 2025 Jun 16.
PubMed 40518459
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06655610
- Acronym / sponsor ID
- eTNS4ADHD / 2401733
- Keywords
- ADHD, Neuromodulation, External trigeminal nerve stimulation, feasibility trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, DenmarkUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active eTNS | Experimental | Device: External Trigeminal Nerve Stimulation |
| Sham eTNS | Sham comparator | Device: Sham device |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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:
- An Intelligence quotient (IQ) below 70 measured by the Wechsler Intelligence Scale for Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Trigeminal Nerve StimulationActive 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 | Active eTNS |
| Sham deviceThe 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. | Device | Sham eTNS |
Primary outcome
The proportion of participants assessed for eligibility who consent to inclusion and randomization
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.
Compliance with the intervention
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.
Acceptability of the intervention
Time frame: 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
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.
Use of concomitant treatment
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.
Safety and adverse events
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Derived from this study: PubMed 40518459Edemann-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 Adolesc Psychiatry. 2025 Dec;34(12):3833-3842. doi: 10.1007/s00787-025-02786-7. Epub 2025 Jun 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ole Jakob Storebø, Professor principal investigator
Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Trigeminal Nerve Stimulation in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ole Jakob Storebø, Professor (452-496-5917, ojst@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants assessed for eligibility who consent to inclusion and randomization (time frame: Four weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06655610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.