NCT06655610

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Psychiatric Research Unit, Region Zealand, Denmark · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ADHD - Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2024-12-05
• Primary completion: 2026-08-31
• Completion: 2026-11-25
• First posted: 2024-10-23
• Last updated: 2026-03-09

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study