FDA OKs first medical device to treat ADHD in children

The first medical device to treat childhood attention deficit hyperactivity disorder, or ADHD,...

Posted: Apr 22, 2019 3:50 AM
Updated: Apr 22, 2019 3:56 AM

The first medical device to treat childhood attention deficit hyperactivity disorder, or ADHD, was OK'd Friday by the US Food and Drug Administration. Designated for children ages 7 to 12 who are not currently on medication for the disorder, the device delivers a low-level electrical pulse to the parts of the brain responsible for ADHD symptoms.

"This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind," Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, said in a statement.

Called the Monarch external Trigeminal Nerve Stimulation System, eTNS,and marketed by NeuroSigma, the treatment is only available by prescription and must be monitored by a caregiver.

The pocket-sized device is connected by wire to a small adhesive patch placed on the child's forehead above the eyebrows. Designed to be used at home while sleeping, it delivers a "tingling" electrical stimulation to branches of the cranial nerve that delivers sensations from the face to the brain.

A clinical trial of 62 children showed that the eTNS increases activity in the regions of the brain that regulate attention, emotion and behavior, all key components of ADHD.

Compared to a placebo, children using the device had statistically significant improvement in their ADHD symptoms, the FDA said, although it could take up to four weeks to see improvement.

Authors of the clinical trial called for additional research to examine if the response to treatment will last over time, and its potential impact on brain development with prolonged use.

Stephen Hinshaw, a professor of psychology at University of California, Berkeley, has led a large research study of ADHD since 1992. He said the pro of the device is that it "appears to be safe, and the initial study is thoughtful and promising."

However, the FDA's sign-off was based on just the one "single, small, short-term trial -- which did not compare eTNS to established treatments." The trial, he said, was bound to get hopes up, but "far more research is needed to demonstrate ultimate efficacy."

According to the NeuroSigma website, the device is not currently covered by insurance and could cost just over $1,000 for the starter kit.

No serious side were reported during the clinical trial, the FDA said, but common side effects could include fatigue, sleepiness or trouble sleeping, teeth clenching, headache and an increase in appetite.

The device should not be worn by children under the age of 7, or any child on an insulin pump, pacemaker or implanted neurostimulator. It should also not be used near a cell phone, the FDA said, because the phone's low levels of electromagnetic energy may interrupt the therapy.

ADHD is among the most common neurodevelopmental disorders of childhood. According to the US Centers for Disease Control and Prevention, children with ADHD might have trouble paying attention, controlling impulsive behaviors or be overly active. Doctors typically recommend a few treatment options for children: medication, behavior modification or both. Some commonly prescribed medications are amphetamine/dextroamphetamine, known as Adderall; methylphenidate, known as Concerta or Ritalin; and lisdexamfetamine, known as Vyvanse.

While not familiar with the specifics of the eTNS device, Atlanta pediatrician Dr. Jennifer Shu said she welcomes ADHD treatment options that don't involve medication.

"I would encourage families to talk with their pediatrician or pediatric neurologist to see if this system might be a good option for their child," Shu said.

The device was previously approved for the treatment of epilepsy and depression in Europe and Canada. Studies at UCLA found the stimulation decreased seizure activity by inhibiting overactive neurons in one section of the brain, while stimulating blood flow in the areas that control mood, attention and executive function.

The device has also been investigated as a possible treatment for traumatic brain injury in veterans.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 173626

Reported Deaths: 2457
CountyCasesDeaths
Multnomah34641566
Washington23309229
Marion20037299
Clackamas15216204
Lane11478144
Jackson9846127
Umatilla795383
Deschutes698772
Linn410763
Yamhill407074
Malheur342558
Polk341752
Klamath340859
Josephine304262
Douglas302765
Benton272518
Jefferson205932
Coos196631
Columbia153326
Union141124
Lincoln129720
Wasco128628
Hood River112429
Morrow107815
Clatsop8838
Crook86819
Baker85114
Curry5919
Tillamook5763
Lake4137
Grant4044
Harney3046
Wallowa1575
Sherman570
Gilliam551
Wheeler251
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 3714587

Reported Deaths: 60922
CountyCasesDeaths
Los Angeles122811823601
Riverside2972154525
San Bernardino2944644544
San Diego2745663662
Orange2687624886
Santa Clara1167722013
Kern1077641317
Sacramento1010581646
Fresno1004311642
Alameda850891475
Ventura802301000
San Joaquin714311334
Contra Costa66839781
Stanislaus603061028
Tulare49383829
Monterey43260352
San Mateo41050560
San Francisco35947517
Santa Barbara33830446
Solano31875239
Merced31196452
Sonoma29632311
Imperial27920718
Kings22755245
Placer21751283
San Luis Obispo20917256
Madera16234239
Santa Cruz15554203
Marin13851226
Yolo13547199
Shasta11677217
Butte11529196
El Dorado9688109
Napa965479
Sutter9268109
Yuba609844
San Benito596963
Lassen566624
Tehama543056
Nevada444775
Tuolumne406664
Mendocino398747
Amador361646
Humboldt358737
Lake339943
Glenn235425
Colusa219216
Calaveras205551
Siskiyou194021
Inyo141738
Del Norte12747
Mono12734
Plumas6906
Modoc4884
Mariposa4197
Trinity3985
Sierra1100
Alpine880
Unassigned610
Medford
Partly Cloudy
80° wxIcon
Hi: 78° Lo: 39°
Feels Like: 78°
Brookings
Partly Cloudy
48° wxIcon
Hi: 73° Lo: 45°
Feels Like: 46°
Medford
Clear
80° wxIcon
Hi: 52° Lo: 27°
Feels Like: 78°
Medford
Partly Cloudy
80° wxIcon
Hi: 81° Lo: 38°
Feels Like: 78°
Klamath Falls
Clear
67° wxIcon
Hi: 64° Lo: 33°
Feels Like: 67°
Very warm Sunday
KDRV Radar
KDRV Fire Danger
KDRV Weather Cam

Community Events