External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
NCT ID: NCT06655610
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-05
2025-11-25
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active eTNS
External Trigeminal Nerve Stimulation
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 eTNS
Sham 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.
Interventions
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External Trigeminal Nerve Stimulation
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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
7 Years
17 Years
ALL
No
Sponsors
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Psychiatric Research Unit, Region Zealand, Denmark
OTHER
Responsible Party
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Ole Jakob Storebø
Professor
Principal Investigators
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Ole Jakob Storebø, Professor
Role: PRINCIPAL_INVESTIGATOR
Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
Locations
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Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark
Slagelse, Region Sjælland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Ole Jakob Storebø, Professor
Role: primary
Henriette Edemann-Callesen, Phd, MD
Role: backup
References
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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 Jun 16. doi: 10.1007/s00787-025-02786-7. Online ahead of print.
Other Identifiers
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2401733
Identifier Type: -
Identifier Source: org_study_id