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An innovative, non-medication treatment option for children with ADHD
About the size of a cell phone, the Monarch external trigeminal nerve stimulation (eTNS) device connects to a disposable patch placed on your child’s forehead at bedtime. Once turned on, the device sends low stimulating pulses to the trigeminal nerve through the patch overnight.
What can you expect from eTNS treatment?
Full effects are typically seen within 4 weeks
Device performance was established in two clinical trials. Trials suggest that a response to the Monarch eTNS System
may take up to 4 weeks to become noticeable.
The effectiveness and tolerability of this device were first seen in an 8-week study of 24 children aged 7-14 years being treated for ADHD. This trial showed a 47% decrease in the ADHD Rating Scale IV (ADHD-RS-IV) score and a responder rate of 71% on the Clinical Global Impressions Scale-Improvement (CGI-I) scale after 8 weeks.
FREQUENTLY ASKED QUESTIONS
Why is the Monarch eTNS System only used for children not taking ADHD medications?
Aside from perceived stigmas associated with ADHD, parents and caregivers may have concerns about psychotropic medication for their children. Now there’s another choice you can offer parents: a noninvasive neuromodulation treatment device based on research funded by the National Institute of Mental Health (NIMH).
Can adults with ADHD use the Monarch eTNS System?
The Monarch eTNS System is FDA cleared for use in patients who are 7 to 12 years old and otherwise meet the intended use criteria. Currently, there have been no research studies involving adults with ADHD, so the safety and effectiveness of the device in treating adults with ADHD are unknown.
Will I be reimbursed for the Monarch eTNS System by my insurance?
Typically, new products approved for the treatment of ADHD are not immediately reimbursed by patients' insurance. The Monarch Pediatric Care Program will handle prescriptions for the Monarch eTNS System, and work with your insurance company to determine coverage. Care Program team members can also assist in determining the best purchasing options for your family’s budget.
For additional assistance with access, contact the Monarch Pediatric Care Program at 877-765-7660.
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How does it work?
- Treatment for ADHD is designed to help refocus the brain, much like glasses are used to help near-sighted children see better. The Monarch eTNS System helps to regulate the brain areas linked to ADHD symptoms via the trigeminal nerve, the body's thickest nerve
- The trigeminal nerve has branches that terminate close to the skin's surface, just above the eyebrows. This nerve is a significant pathway to critical brain regions associated with attention, mood, and self-control
- Using mild stimulating pulses delivered to the nerve through the skin, the Monarch eTNS System increases activity in these key brain regions. Brain imaging studies have documented these effects
- The Monarch eTNS System is convenient and easy to use. Just smooth the disposable patch onto your child’s forehead at bedtime. Turn on and adjust the device for overnight treatment. The pulsing effects are mild and not intrusive. Children have described the stimulation as a tingling sensation on the skin. The treatment works while your child is sleeping. In the morning, remove the patch when your child wakes up
Everyone used the treatment as directed, side effects were minimal, and no child withdrew from the study due to adverse events.
Based on these positive results, the treatment was studied in another 4-week controlled study. Children with ADHD ages 8-12 years were randomly assigned to active treatment or sham-controlled (placebo) treatment (sham-controlled treatment means that the device didn’t provide nerve stimulation).
Symptom improvements were measured using the ADHD-RS-IV rating scale. At the end of the 4-week study:
- Children in the active group had a decrease of 27% vs 16% among children in the placebo group
- 52% of children in the treatment group showed a clinically meaningful improvement in ADHD symptoms compared to 14% in the placebo group
The most common side effects observed with eTNS use include drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. In the clinical trial, trouble sleeping occurred equally in the active and sham treatment groups. No serious adverse events have been associated with the use of the device.
A low-risk treatment option
Stay up to date on the Monarch eTNS System
Customer support for patients
If you have any questions about the Monarch eTNS System, please contact a Monarch Pediatric Care Program representative at 877-765-7660.
The Monarch eTNS System is easier to get than you think
COPAY
The Monarch Pediatric Care Program will contact your insurance company to determine coverage and work with your healthcare provider on any prior authorizations needed. Our team of patient support advocates will work with you on navigating the complex insurance environment and assist in finding a fulfillment partner. We can also assist in determining the best purchasing options for your family’s budget.
For additional assistance, you can contact the Monarch Pediatric Care Program at 877-765-7660.
Ask your doctor for a prescription
If you are interested in participating in the Monarch Pediatric Care Program and your physician agrees that the Monarch eTNS System is right for your child, ask your doctor to fill out the enrollment form and fax it directly to 703-832-8447. A Monarch Pediatric Care Program representative will contact you to discuss the next steps.
FOR PHYSICIANS
Aside from perceived stigmas associated with ADHD, parents and caregivers may have concerns about psychotropic medication for their children. Now there’s another choice you can offer parents: a noninvasive neuromodulation treatment device based on research funded by the National Institute of Mental Health (NIMH).
A safe and effective non-medication treatment for children ages 7 to 12 years1,2
The Monarch eTNS System is the first FDA-cleared device for ADHD with proven efficacy in alleviating ADHD symptoms. This non-medication, minimal-risk monotherapy is used by parents or caregivers for at-home treatment of children ages 7 to 12 years who are not currently taking prescription medication for ADHD.
Monarch eTNS System: Proven effective1,2
The Monarch eTNS System:
- A cell phone-sized device that connects to a disposable patch placed on the child’s forehead at bedtime
- The device sends low stimulating pulses to the trigeminal nerve through the patch overnight
- The pulsing effects are mild and not intrusive, and children have described the stimulation as a tingling sensation on the skin
- The device is intended for use under the supervision of a caregiver during periods of sleep
- In the morning, when the child wakes up, the patch is removed
The Monarch eTNS System is convenient and easy for parents and caregivers to use. Because it is a non-medication option, the device meets the needs of parents and caregivers who fear first-use of psychotropic medications. Clinical trials suggest that a response to eTNS may take up to 4 weeks to become noticeable.
A non-medication prescription monotherapy designed for bedtime use overnight
Device performance established in 2 clinical trials1,2
- Efficacy and tolerability were first described in an 8-week, open-label, pilot study of eTNS treatment of 24 children diagnosed with ADHD aged 7-14 years1
- Participants were assessed weekly with parent-and physician-completed measures of ADHD symptoms and executive functioning, treatment compliance, adverse events, and side effects
- After 4 weeks of nightly use, 64% of the study group were rated as “improved” or “improved very much” on the Clinical Global Impression–Improvement (CGI-I) scale
- After 8 weeks, 71% had achieved that rating
- ADHD Rating Scale IV (ADHD-RS-IV) scores showed a 47% decrease, compliance was 100%, and no child withdrew from the study due to adverse events1
- The first double-blind, randomized, sham-controlled trial of eTNS as monotherapy for children with ADHD2
- In a 4-week trial of 62 children ages 8-12 years with an open-label extension, efficacy was assessed by improvements on the ADHD-RS-IV rating scale
- Significant improvements in ADHD-RS-IV scores were seen in the active treatment group at the end of 4 weeks
- Significant changes were also seen in quantitative electroencephalogram (EEG) recordings among children in the active treatment group compared to those in the sham treatment group
- After treatment was stopped, the ADHD-RS-IV scores worsened in both groups but remained lower in the active treatment group
The most common side effects observed with eTNS use include drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. No serious adverse events have been associated with use of the device. For full safety information, please consult the instructions for use.
A safety profile you can trust
The Monarch Pediatric Care Program will contact the parent’s or caregiver’s insurance company to determine coverage and work with them on any prior authorizations needed. The Care Program team of patient support advocates will work with parents and caregivers to navigate the complex insurance environment and assist in finding a fulfillment partner. Care Program team members can also assist in determining the best purchasing options for the family’s budget.
For additional assistance with access, contact the Monarch Pediatric Care Program at 877-765-7660.
If you have any questions about the Monarch eTNS System, please contact our Medical Affairs department at medical.affairs@neurosigma.com
The Monarch eTNS System is available to physicians and patients through the Monarch Pediatric Care Program
References: 1. McGough JJ, Loo SK, Sturm A, et al. An eight-week, open-label pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder. Brain Stimulation. 2015;8:299-304. 2. McGough JJ, Sturm A, Cowen J, et al. Double-blind, sham-controlled, pilot study of trigeminal nerve stimulation for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2019;58(4):403-411.
WHAT IS MONARCH eTNS®
Evaluations for ADHD
Where can I have my child evaluated for ADHD?
Patients can seek an evaluation for a diagnosis of ADHD with a medical professional of their choice. If diagnosed, the medical provider may prescribe the Monarch as treatment.
Options for an evaluation and diagnosis include:
- Your child’s pediatrician
- Telehealth psychiatric provider, such as Remedy Psychiatry
- Your local psychiatrist, hospital, or mental health clinic
- Interested patients can contact the UCLA Department of Child and Adolescent Psychiatry, which helped develop the Monarch as a treatment for pediatric ADHD