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August 31, 2021
A University of California at Los Angeles (UCLA) team has just reported on the first-ever, double-blinded, sham-controlled study of trigeminal nerve stimulation (TNS) for treating ADHD. The trigeminal nerve is the largest cranial nerve. It enables facial sensation, as well as biting and chewing.
Over four weeks, researchers fitted 62 eight-to-twelve-year-old children with electrodes while they slept; 32 got an active low current, the rest none at all. The active and sham setups were identical in appearance. The children were told, pulses may come so fast or so slowly that the nerves in the forehead might or might not detect a sensation. After the four weeks, there was an additional-blinded week without intervention.
The primary efficacy outcome measure was the clinician-completed ADHD-RS total score, derived from parent interviews and available clinical information. It was completed at the onset of the study, and repeated over subsequent weeks. The Clinical Global Impression (CGI) score was used as a secondary outcome measure.
Both groups of children showed significant reductions in ADHD symptoms over the first week. But University of California at Los Angeles (UCLA) teams leveled off during the remaining three weeks for the group with sham treatment, while scores continued to decline for those in the group with actual stimulation. The standardized mean difference (SMD) between groups was 0.5.
By the conclusion of week 4, 52 percent of those in active treatment were improved or very much improved, as indicated by CGI scores; only a 14percent did as well with the sham treatment. The number needed to treat was just 3.
After discontinuation of treatment, total scores in both groups rose at similar rates. At the end of week 5, CGI ratings for active treatment showed 13 percent improvement over baseline, versus 7 percent for sham treatment. The SMD was 0.46, once again indicating the persistence of a medium effect size a week after treatment cessation.
The effect sizes computed for TNS are roughly comparable to effect sizes for non-stimulant medication, but less than those for stimulants.
Though the active group had significant gains in weight and pulse over the sham group, there were no serious adverse events in either group.
The authors concluded: Results from the Early Impressions Questionnaire showed no differences in outcome expectations between treatment groups after 1 week of using the randomized device, suggesting that our sham procedures successfully accomplished double-blinding of group assignment. Improvements seen in the active and sham groups at week 1 likely reflect some placebo response secondary to the high level of parental involvement in administering treatment. Nonetheless, a further improvement over subsequent weeks with active TNS suggests the emergence of true treatment effects TNS is a non-medication, minimal-risk intervention with proven efficacy in alleviating ADHD symptoms. Although the present study finds that only slightly more than half of those receiving therapy have clinically meaningful improvement, the virtual lack of significant side effects should make it a popular treatment choice for many patients with ADHD, particularly for parents who prefer to avoid psychotropic medication.
Nevertheless, one must keep in mind that this is a single uncomplicated study with a small sample size. Further, studies with larger numbers of participants are needed, both to confirm the efficacy and to further explore the weight gains and higher pulse rates in the treatment group.
James J. McGough, MD, Alexandra Sturm, Ph.D., Jennifer Cowen, Ph.D., Kelly Tung, BS, Giulia C. Salgari, MS, Andrew F. Leuchter, MD, Ian A.Cook, MD, Catherine A. Sugar, Ph.D., Sandra K. Loo, Ph.D., "Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder," Journal of the American Academy of Child &Adolescent Psychiatry, Vol. 58, No. 4 (April 2019), 403-411.
The persistent shortage of ADHD medications has been more than a simple annoyance for patients at the pharmacy; the inconsistent availability of these medications has had deep impacts on the daily lives of those struggling without them. While public discourse has pointed fingers at over-prescribing or at restrictive DEA quotas, a recent economic evaluation in JAMA Health Forum suggests we’ve been looking in the wrong direction for an answer to what is causing this.
The reality of the shortage is less about increased demand and more about a fragile, globalized supply chain that snapped at a critical link.
Debunking the "Quota Myth":
The prevailing narrative suggested that the Drug Enforcement Administration (DEA) was stifling production by refusing to raise quotas. However, the data tells a different story. In 2022, manufacturers collectively met only about 70% of their allotted production quotas.
So we know that the problem wasn't that this DEA quota ceiling was too low. In fact, most manufacturers couldn't even reach it. Even when accounting for exports and domestic retail, production remained significantly below the legal limit. Even if the DEA had doubled its quotas, these medications still likely wouldn't have magically appeared on pharmacy shelves.
The most striking finding in the study is the correlation between the shortage and a sharp decline in the import of raw Active Pharmaceutical Ingredients (APIs). For the past decade, Germany has accounted for over 85% of US amphetamine imports. In 2022, these imports dropped by approximately 36.7%. When the API doesn't arrive at the factory, production for medium and small manufacturers grinds to a halt. Unlike larger pharmaceutical giants, these smaller players often lack the inventory cushion or flexibility to quickly pivot to a new supplier.
When the primary supply of amphetamine-based stimulants (like Adderall) faltered, it triggered a secondary crisis. Patients and clinicians, seeking alternatives, shifted toward lisdexamfetamine (Vyvanse) and methylphenidate (Ritalin/Concerta).
If we view this shortage purely through a regulatory or clinical lens, we miss the underlying cause of the crisis. The pharmaceutical industry has become a victim of its reliance on "just-in-time manufacturing” and highly concentrated sourcing. Because over 30% of APIs for the US market are produced in just one or two facilities globally, the system isn't just inefficient; it’s brittle. We are, in a sense, trapped in a system that prioritizes cost-reduction over the resilience required for public health.
The researchers suggest several policy shifts to prevent a repeat of this supply chain failure:
The ADHD medication shortage wasn't a failure of clinical oversight or a sudden surge in "TikTok-driven diagnoses”, as many have suggested. It was a failure of logistics. It reminds us that the path from a lab in Germany to a patient's hand in the US is far more precarious than we realized.
ADHD is a neurodevelopmental condition rooted in delayed or atypical maturation of the prefrontal cortex (the brain region that governs self-regulation). This maturational lag underlies the hallmark difficulties with attention, hyperactivity, and impulsivity, and also impairs what researchers call executive function: the cognitive toolkit we rely on for working memory, impulse control, mental flexibility, emotional regulation, and the ability to tolerate delays in reward.
The Background:
Standard treatments work through two main routes. Stimulant and non-stimulant medications are considered very safe and effective treatments, but are not without risk of side effects and are not appropriate for every ADHD patient. Behavioral and psychosocial interventions can improve self-regulation and social functioning, but they require sustained effort and produce variable results. These limitations have kept the search for better alternatives active.
One candidate that has drawn growing attention is transcranial direct current stimulation (tDCS). The technique is appealingly simple: a weak electrical current is applied to the scalp through small electrodes, modulating the excitability of neurons in the underlying cortex without requiring surgery, anesthesia, or significant discomfort. Its safety profile and ease of use have made it attractive to researchers.
The Study:
A newly published meta-analysis set out to give the technique its most rigorous test yet, pooling results from randomized controlled trials, including crossover designs, that compared active tDCS against sham stimulation in people with ADHD across all age groups.
The Results:
The findings were consistently null. Across seven trials enrolling 303 participants, tDCS produced no significant reduction in overall ADHD symptom severity compared with sham. Breaking symptoms into their components made no difference: neither hyperactivity/impulsivity nor inattention improved. Turning to executive function, 18 studies with 872 participants found no meaningful gain in inhibitory control, and 12 studies with 506 participants found the same for working memory. Smaller bodies of evidence, including three studies on cognitive flexibility (122 participants) and two on hot executive function, the motivational and emotional dimension of self-regulation (86 participants), similarly came up empty. Variation in outcomes across studies was small to moderate, and there was no evidence of publication bias skewing the picture.
The authors’ conclusion was succinct: tDCS was well tolerated but “did not demonstrate significant overall efficacy for core ADHD symptoms or executive functions.”
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Disordered eating (a broad category of persistent, harmful patterns in eating or weight control) affects between 5% and 22% of children and adolescents worldwide, with similar rates seen in the United States. The consequences are far-reaching: these conditions are linked to bone fractures, anemia, malnutrition, dental erosion, obesity, diabetes, hypertension, and elevated cholesterol and triglycerides. They also carry one of the highest mortality rates of any psychiatric illness.
Eating disorders rarely occur in isolation. They frequently arise alongside other psychiatric and neurological conditions. Yet, until now, no large-scale study had examined these co-occurrences in a nationally representative U.S. sample. A new study addresses that gap, focusing on children and adolescents aged 6–17 and the conditions most commonly associated with disordered eating, including ADHD.
The Study:
Researchers drew on data from the 2022–2023 National Survey of Children's Health (NSCH), a nationally representative, cross-sectional survey covering all 50 states and Washington, D.C. Households were selected using stratified, address-based sampling, and parents or guardians completed surveys about one randomly selected child per household. The final sample included 68,000 children and adolescents.
Results:
After accounting for factors including sex, age, race and ethnicity, household income, educational attainment, insurance status, and household language, children and adolescents with ADHD were 2.6 times more likely to have some form of disordered eating compared to their typically developing peers.
The elevated risk appeared across a range of specific behaviors:
A greater tendency toward using diet pills, laxatives, or diuretics was also observed in the ADHD group, though this finding did not reach statistical significance.
The Take-Away:
These findings underscore a need to improve both prevention and treatment strategies for disordered eating, particularly in children and adolescents who have ADHD. Clinicians working with this population are advised to screen for a wide spectrum of disordered eating behaviors.
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