The U.S. Food and Drug Administration (FDA) has given the go-ahead for marketing the first prescription-only medical device that addresses the symptoms of attention deficit hyperactivity disorder (ADHD).
Approved for patients ages 7 to 12 who are not on medication, the Monarch external trigeminal nerve stimulation (eTNS) system from the bioelectronics company NeuroSigma is a cellphone-size device that works by transmitting low-level electronic stimulation to the brain. The European Union and Canada have already green-lighted this form of noninvasive therapy for ADHD, epilepsy, and depression in patients ages 7 and older.
The Centers for Disease Control and Prevention estimates that about 9.4 percent of American children between ages 2 and 17 (6.1 million) have received a diagnosis of ADHD. For these youngsters, the product may be an “innovative, safe and effective” alternative to ADHD drugs, according the FDA.
“We look forward to offering parents a non-pharmacological treatment option for pediatric ADHD in the United States," said Leon Ekchian, PhD, the president and CEO of the Los Angeles–based NeuroSigma, in a statement.
Significant Improvements in Attention and Behavior
Designed for home use under adult supervision, the electronic tool sends a pulse through a wire to a small electrode patch that sticks to the individual’s forehead. Powered by a 9-volt battery, the device attaches to the child’s clothes and delivers a mild tingling sensation to the skin throughout the night while the child is sleeping. The signal stimulates branches of the trigeminal nerve (the largest cranial nerve), which relays those pulses to parts of the brain associated with regulating attention, emotion, and behavior.
Clinical trials designed to test the effectiveness of the system compared it with a placebo (dummy) device as a sole treatment in 62 children with moderate to severe ADHD. The children spent four weeks of nightly sleep connected to either the eTNS or placebo, after which investigators from the University of California in Los Angeles observed that ADHD symptoms improved significantly in the eTNS group over the placebo group.
An ADHD rating scale was used to measure the severity and frequency of the disorder’s symptoms. Higher scores indicated more behavioral and attention problems, such as having trouble waiting their turn, making mistakes in following instructions, daydreaming, and fidgeting.
By the study’s end, eTNS participants had lowered their average rating scale score about 11 points, from 34.1 to 23.4, while scores for placebo-receivers dropped about 6 points, from 33.7 to 27.5.
Another Option for Children and Parents
"Our current treatments mostly depend on medication with some role for behavioral therapies,” said James McGough, MD, a professor and child psychiatrist at the Jane & Terry Semel Institute for Neuroscience and Human Behavior at UCLA, in a statement. “This treatment was well accepted by patients and families, compliance was high, and there were no clinically important side effects. TNS has great potential as an additional option for managing ADHD."
Judging by these results, the treatment may take up to four weeks to produce any benefit. The FDA advises that patients consult with their physicians after that point to assess how care should proceed.
Alan Manevitz, MD, a psychiatrist who treats adolescents and adults with ADHD at Lenox Hill Hospital in New York City, sees potential for the product with his patients. “The study seemed to show that attention and hyperactivity improved in the short-term for those receiving the electronic stimulation,” says Dr. Manevitz, who was not involved with the study. “I would consider it, especially for those who have not responded well to commonly used stimulants [such as Ritalin (methylphenidate) and Adderall (amphetamine)].”
While the eTNS system seemed to be safe, producing no serious adverse events, the FDA does list side effects, such as drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache, and fatigue.
Currently, the eTNS system is not covered by insurance. NeuroSigma estimates a cost of about $900 for a starter kit. The biotech firm encourages consumers interested in the product to contact its patient support team.
Because the symptoms of ADHD can be long-lasting and can hamper a child’s normal development, Manevitz calls for more research to understand the device’s long-term impact on brain development and whether it can be used in conjunction with other treatments like medications and behavioral therapy.
“It’s early in the game with eTNS,” says Manevitz. “I think this is a thoughtful study, and we will see how it plays out over time.”
He adds that questions remain: Will the results be sustained? Are there any other potential side effects that will come out over time? How does this work in conjunction with other treatments?
“The device has the potential to enter the paradigm of treatment, but it’s not the magic bullet that cures ADHD or singularly puts ADHD in remission,” says Manevitz.