Abstract
The Monarch external Trigeminal Nerve Stimulation (eTNS) device has been approved by the U.S Food and Drug Administration (FDA) for non-pharmaceutical treatment of attention-deficit/hyperactivity disorder (ADHD) in children. Previous research into the use of eTNS to treat other psychiatric and neurological disorders has shown the device to be well-tolerated with few adverse events. Here, we report on the use of eTNS treatment in a case series of four children with ADHD in Denmark, using the NeuroSigma Monarch eTNS stimulator.
Four children aged 7–12 years, newly diagnosed with ADHD and treatment naïve, tested the device for four weeks. During the intervention the parents were interviewed three times, two and four weeks after the start of intervention and again two weeks after the end of intervention. In this qualitative study a semi-structured interview guide was used with topics including user friendliness, general experience with the intervention, potential adverse events and the parents' experience with changes in the children's ADHD symptoms, sleep and wellbeing.
Our results showed that the Monarch eTNS stimulator is user-friendly. It should be noted that one child, who is known to move excessively during sleep, got tangled in the cables. This required that the parents often checked him at night. Due to the novelty of this type of intervention, we observed that it was essential that the reason for using eTNS as a treatment is communicated appropriately at school and to the children's peers, for the child to feel understood and accepted. We found that the current intensity had to be increased for three out of the four children during the four-week experiment to enable the parents to report on potential changes in ADHD symptoms. The child who received the highest current intensity also displayed the most pronounced decrease in ADHD symptoms as indicated by the parents. The sleep patterns of three of the children potentially changed during the intervention. The parents of two children reported that they observed the children having a longer and deeper sleep. One child with bedtime avoidance improved, as he now went straight to bed and fell asleep much faster. Two children stopped waking up at night and going to their parents’ beds. These observations indicate that they had a better sleep quality, and this is a topic for further investigation. Only few mild adverse events were reported.
Four children aged 7–12 years, newly diagnosed with ADHD and treatment naïve, tested the device for four weeks. During the intervention the parents were interviewed three times, two and four weeks after the start of intervention and again two weeks after the end of intervention. In this qualitative study a semi-structured interview guide was used with topics including user friendliness, general experience with the intervention, potential adverse events and the parents' experience with changes in the children's ADHD symptoms, sleep and wellbeing.
Our results showed that the Monarch eTNS stimulator is user-friendly. It should be noted that one child, who is known to move excessively during sleep, got tangled in the cables. This required that the parents often checked him at night. Due to the novelty of this type of intervention, we observed that it was essential that the reason for using eTNS as a treatment is communicated appropriately at school and to the children's peers, for the child to feel understood and accepted. We found that the current intensity had to be increased for three out of the four children during the four-week experiment to enable the parents to report on potential changes in ADHD symptoms. The child who received the highest current intensity also displayed the most pronounced decrease in ADHD symptoms as indicated by the parents. The sleep patterns of three of the children potentially changed during the intervention. The parents of two children reported that they observed the children having a longer and deeper sleep. One child with bedtime avoidance improved, as he now went straight to bed and fell asleep much faster. Two children stopped waking up at night and going to their parents’ beds. These observations indicate that they had a better sleep quality, and this is a topic for further investigation. Only few mild adverse events were reported.
| Original language | English |
|---|---|
| Article number | 100154 |
| Journal | Psychiatry Research Case Reports |
| Volume | 2 |
| Issue number | 2 |
| Number of pages | 5 |
| ISSN | 2773-0212 |
| DOIs | |
| Publication status | Published - Dec 2023 |