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

NCT06655610 | Recruiting FDA Device

• 1 other identifier: 2401733
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Neuromodulation; External trigeminal nerve stimulation; feasibility trial

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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?

  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.

  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.

  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.

  Four weeks

Other Outcomes (11)

• ADHD core symptoms

  Four weeks

• Absence from school

  Four weeks

• Emotional liability

  Four weeks

Study Arms (2)

Active eTNS

EXPERIMENTAL

Device: External Trigeminal Nerve Stimulation

Sham eTNS

SHAM COMPARATOR

Device: Sham device

Interventions

Sham device 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 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.

Sham eTNS

External Trigeminal Nerve Stimulation DEVICE

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.

Active eTNS

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Psychiatric Research Unit, Region Zealand, Denmark: lead

Study Sites (1)

Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark

Slagelse, Region Sjælland, 4200, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 40518459 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ole Jakob Storebø, Professor

  Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole Jakob Storebø, Professor

CONTACT

452-496-5917; ojst@regionsjaelland.dk

Henriette Edemann-Callesen, Phd, MD

CONTACT

452-834-3531; henriette.callesen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: October 23, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)