8
III. Indications For Use
The
Monarch
external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of
pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7
through 12 years old who are not currently taking prescription ADHD medications.
The device is to be used for patient treatment by prescription only and is intended to be used in
the home under the supervision of a caregiver during periods of sleep.
IV. Trigeminal Nerve Stimulation Therapy
The main role of the trigeminal nerve is to convey sensation information from the face into the
brain. External trigeminal nerve stimulation (eTNS) uses this natural pathway to send therapeutic
signals into the brain. The trigeminal nerve connects directly from the face to the brainstem, and
from there information is sent to other key brain regions thought to be involved in medical
conditions such as ADHD (alternatively called hyperkinetic disorder or HKD). While the exact
mechanism of action of eTNS is not yet known, neuroimaging studies have shown that eTNS
increases activity in brain regions that are known to be important in regulating attention,
emotion, and behavior. These findings are supplemented by basic science studies in animals,
as well as clinical studies in humans. For more information on eTNS, please visit
www.monarch-etns.com.
