There is a new category in the crowded ADHD treatments market that is growing and capturing attention. Inc. magazine coined it “digital therapeutics:” technologies that have measurable effects on, in this case, ADHD symptoms. Most important, the products’ benefits are supported by research. Many companies have conducted and published clinical studies on these natural ADHD remedies in peer-reviewed journals. And they have submitted the research to the Food and Drug Administration for evaluation and approval.
Here, ADDitude spotlights three new digital therapies for ADHD.
When parents talk about video games — particularly in the ADHD community, where children may be especially susceptible to the games’ potential negative effects — the word “therapeutic” doesn’t come up. But a new digital program hopes to change that. Boston-based Akili Interactive has developed an engaging game that may function as a form of treatment, reducing impulsivity and inattention while the child with ADHD plays.
The game — known as AKL-T01 — is currently under FDA review. If approved, the game would be the first video game to be available only by prescription. Based on a game called NeuroRacer — designed by neuroscientist Adam Gazzaley, M.D., Ph.D., founding Director of the University of California, San Francisco’s Neuroscape, and Akili’s chief science advisor — AKL-T01 is played on a tablet and uses specialized algorithms to increase or decrease the game’s difficulty, depending on a player’s performance. The goal is to keep kids with ADHD challenged but not overloaded to stimulate specific areas of the brain and improve attentional control, says Akili CEO Eddie Martucci, Ph.D.
Akili has not specified the nature of gameplay, but “the technology is designed to increase amplitude in the frontal lobe—which controls attention and [cognition]—and the efficiency of communication to other regions,” Martucci says.
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According to several pieces of research conducted on AKL-T01, those brain-based changes appear to be correlated with decreased ADHD symptoms. One study, conducted by Scott Kollins, Ph.D., a psychiatry professor at Duke University and an advisor to Akili, was published in the peer-reviewed journal PLOS ONE1 in 2018. It found that after 28 days of at-home treatment — in which the game was played five days a week, for 30 to 45 minutes at a time — children with ADHD showed significant improvement on measures of attention, working memory, and inhibition as measured by TOVA, the BRIEF, and the CANTAB. Another clinical trial conducted by Kollins, known as STARS2, showed that children with ADHD who were randomized to play AKL-T01 showed larger improvements in inattention than those who played a control game. (The STARS trial has yet to be published in a peer-reviewed journal, but top-line results were announced in December 2017.)
“On outcomes that measure attentional functioning, we’ve seen in multiple studies that, after a month of using AKL-T01, children show robust improvements,” Martucci states. Side effects, including headache, frustration, or nausea, were rare — occurring in only six percent of patients in the STARS trial — and were typically mild.
Parents whose children spend a lot of time playing video games may be hesitant to add another to the docket. But that may be part of AKL-T01’s appeal, Martucci says. “We’re delivering what could be powerful medicine, in a format that children naturally gravitate to.”
This at-home neurostimulation device, worn around the forehead, sends mild currents of electricity to the brain. FDA-cleared to treat mood disorders and anxiety, the device is thought to reduce symptoms by stimulating the release of neurotransmitters — most notably, serotonin — and decreasing levels of cortisol, a stress hormone that can trigger a range of negative physical and psychological effects. The device is not cleared to treat ADHD, but mood disorders and anxiety often co-occur with the disorder and can exacerbate its symptoms.
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The mechanism of action is similar to electroconvulsive therapy (ECT) but at just a fraction of the strength. The Stimulator’s currents range from 1 to 4 milliamps, explains Charles “Chip” Fisher, chairman of Fisher Wallace Laboratories; ECT, by comparison, operates at anywhere from 800 to 1000 milliamps. Though ECT has had a mixed reputation over the years, evidence has shown it to be fairly effective at treating severe mental health challenges. “The problem is that it’s cumbersome and invasive,” Fisher says. By greatly reducing the strength of the current (the device runs on AA batteries) and allowing at-home treatment, “We’ve harnessed the best aspects of ECT — without any of the side effects.”
More than 250 studies3 have been conducted on ECT, Fisher adds, though none has compared its efficacy head-to-head with other treatment modalities. Still, the device is generally well-tolerated; other than mild headaches, flashing lights that appear at the corners of one’s vision while the device is in use, and a slight tingling sensation, no serious side effects have been observed in more than 30 years of research.
In the first 30 days, it’s recommended that the Stimulator be used twice a day for 20 minutes at a time to treat symptoms of mood disorders and anxiety. After that period, patients can use it on an as-needed basis. Though the success rate has varied across studies, Fisher reports that the success rate is 75 to 80 percent, on average. In one 2014 study, published in the Journal of Affective Disorders4, 83 percent of participants with co-occurring anxiety and mood disorders saw a greater than 50 percent reduction in the severity of their symptoms.
Most people notice benefits, like improved sleep quality or decreased levels of anxiety, within a few days. “If someone hasn’t seen a strong effect in a week or two, it’s likely that he will not,” Fisher notes. Though a formal prescription is not necessary, patients must obtain authorization from a licensed healthcare professional — anyone from an LCSW to an M.D. — to use the device.
Brain training, neurofeedback, and other non-medical treatments for pediatric ADHD have one thing in common: They are used when a child is awake. A new device, cleared by the FDA, is the first high-tech treatment that works while a patient is asleep.
The Monarch eTNS (external Trigeminal Nerve Stimulation) System is an electronic device, about the size of a cell phone, that electrically stimulates the brain’s trigeminal nerve through a patch applied to the forehead before bedtime. The trigeminal nerve is the brain’s largest cranial nerve and is responsible for communicating sensations from the face to other parts of the nervous system—including brain areas involved in mood disorders, epilepsy, and attention. The nerve is thought to provide a pathway to deeper areas of the brain not easily reached by neurostimulation.
TNS therapy is approved in Canada and Europe to treat mood disorders and epilepsy. Early this year, a team of UCLA researchers published the results of the first double-blind, placebo-controlled trial examining the efficacy of the Monarch eTNS on ADHD in children in the Journal of the American Academy of Child and Adolescent Psychiatry.5 They concluded that, compared to a placebo treatment, children who used the Monarch at bedtime for four weeks—under parent supervision—experienced significantly reduced impulsivity, hyperactivity, and inattention, as measured by clinician-administered ADHD rating scales. Children also demonstrated, when hooked up to an EEG, increased activity in specific brain areas, including the right frontal region, thought to be associated with attention.
Results weren’t immediate, with just a quarter of the children showing improvement in the first week. But the efficacy of the treatment appeared to increase over time. By the fourth week, more than half of the children in the active group saw clinically significant improvements in their ADHD symptoms. After the results were published, the FDA announced that it had cleared the Monarch to treat pediatric ADHD.6
In a statement, Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said, “This device offers a safe option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation—a first of its kind.” (The device, for which a prescription is needed, is indicated only for children ages seven to 12 who are not currently taking ADHD medication.)
The study’s lead author, James McGough, M.D., professor and child psychiatrist at the Jane & Terry Semel Institute for Neuroscience and Human Behavior, at the University of California, Los Angeles, said: “I’m excited that we found significant reductions in ADHD symptoms, as well as associated improvements in brain functioning,” after TNS treatment. Only minor side effects, like headaches and fatigue, have been seen in TNS research so far.
The EEG data is promising, co-author Sandra K. Loo, Ph.D., professor in residence at the UCLA Brain Research Institute, said. “Our work suggests that successful treatment response to eTNS appears to address a number of cognitive and neural deficits typically associated with ADHD.” Additional research, she adds, could help identify the children who might best respond to TNS before treatment is initiated.
The American Academy of Pediatrics (AAP) recommends treating ADHD in children and adolescents aged 6 to 18 with FDA-approved medications, plus parent training in behavior modification and behavioral classroom interventions. Research studies like this one conducted by scientists at McGill University have found that “stimulant medications are most effective, and combined medication and psychosocial treatment is the most beneficial treatment option for most adult patients with ADHD.” All ADHD treatment decisions should be made in consultation and coordination with a licensed medical provider.
Devon Frye is a science journalist based in New York.
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View Article Sources
1 Davis et al. “Proof-of-concept study of an at-home, engaging, digital intervention for pediatric ADHD.” PLOS One (Jan. 2018) https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0189749
2Kollins et al. “2.40 A Multicenter, Randomized, Active-Control Registration Trial of Software Treatment for Actively Reducing Severity of ADHD (Stars-Adhd) to Assess the Efficacy and Safety of a Novel, Home-Based, Digital Treatment for Pediatric ADHD.” Journal of the American Academy of Child and Adolescent Psychiatry. (Oct. 2018) https://jaacap.org/article/S0890-8567(18)31475-8/fulltext
3 Southworth S. “A study of the effects of cranial electrical stimulation on attention and concentration.” Integrative Physiological and Behavioral Science(Jan.-Mar. 1999) https://www.ncbi.nlm.nih.gov/pubmed/10381164
4 Barclay et al. “A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid mood disorders.” Journal of Affective Disorders (Aug. 2014) https://www.sciencedirect.com/science/article/abs/pii/S0165032714002134
5 McGough et al. “Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder.” Journal of the American Academy of Child and Adolescent Psychiatry.(Apr. 2019) https://jaacap.org/article/S0890-8567(19)30045-0/fulltext
6 “FDA permits marketing of first medical device for treatment of ADHD” FDA (Apr. 2019) https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-medical-device-treatment-adhd
