ADHD

Attention deficit hyperactivity disorder (ADHD) is a condition characterized by significant difficulties with inattention, hyperactivity, and impulsive behaviors. ADHD is among the most commonly diagnosed psychiatric disorders in children and adolescents, and affects roughly 5.9 million children between the ages of three and 17 in the United States. It is often unappreciated that ADHD can be a chronic disorder, with somewhere between and 30 and 50% of individuals diagnosed in childhood continuing to have symptoms as adults.

ADHD is two to four times more likely to be diagnosed in males than in females, and is associated with poor performance in school and decreased achievement in adulthood. Current management options for ADHD include counseling, lifestyle changes, behavioral therapies and medications. Most of the medications used to treat ADHD are stimulants, and there is significant public controversy regarding the widespread use of these medications in children.

ADHD

A phase I study of eTNS for ADHD showed improvements in symptom severity after 8 weeks that are in-line with those achieved with stimulant medications. For this trial eTNS was used as a standalone treatment.
McGough et al., Amer Psychiatric Assoc, Poster 2013

In May of 2013, results from a Phase I study of eTNS in 24 children were presented at the annual meeting of the American Psychiatric Association in San Francisco. Children ages 7 to 14 were enrolled to receive eTNS nightly as standalone therapy. Symptom severity was assessed prior to using eTNS, and again after 4 weeks and 8 weeks of nightly use. After 8 weeks, symptom severity on the ADHD-RS scale decreased by an average of 47%. There were also significant improvements in sleep quality, and in cognitive function as measured by computer-based neuropsychological testing. These results are highly encouraging and NeuroSigma is currently planning Phase II clinical trials of eTNS for treatment of ADHD.

CAUTION: We have not received approval from the FDA to market our eTNS™ system or proposed sTNS™ system in the United States. Our eTNS™ system and proposed sTNS™ system are classified as investigational devices and are limited by Federal (or United States) law to investigational use only.

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