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Akili: A Novel Approach to Clinical Intervention with Digital Therapeutics
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
The CAVES study was the initial open-label study in 80 children ages 8–12 years old (40 ADHD—40 neurotypical) conducted at three US clinical sites. Children with ADHD were off ADHD medication. The study was designed to evaluate the feasibility, safety, acceptability, compliance, and efficacy of SSME (Project EVO) for improving cognitive function. The study results indicated that EndeavorRx was a well-tolerated at-home digital intervention for four weeks in 8–12-year-old children with and without ADHD, with good ratings of acceptability and high compliance. Preliminary efficacy results supported the hypothesis that the intervention may be effective for improving an objective measure of attention (Test of Variables of Attention: TOVA®, a computerized test cleared by FDA to evaluate the effects of interventions in ADHD) and some aspects of working memory and inhibition, especially in children with greater symptom severity and impaired attention (Davis et al., 2018).
Neurofeedback in an Integrative Medical Practice
Published in Hanno W. Kirk, Restoring the Brain, 2020
56-year-old woman who was recently retired on disability for fibromyalgia. Her physical activity was severely limited due to pain and stiffness every day. Pain and restless legs disrupted sleep initiation and maintenance. She never felt rested and had problems with focus and memory. She had been diagnosed with ADD in the past. Mood was depressed and she was anxious about dealing with and providing for her teenage son as a single mother. Her house and yard were “a mess” because she had neither the energy nor the strength to organize or clean. Past medical history was significant for psoriasis with arthritis and osteoporosis. Medications were numerous and included Concerta, Cymbalta, Lamotrigine, Voltaren, Etodolac, Seroquel, and medications specific for psoriasis. Dietary supplements included multivitamin, CoQ10, curcumin, S-adenosyl methionine (SAM-e), vitamin D3, zinc, and krill oil. Family history revealed attention disorders and alcoholism. The patient was a non-smoker and non-drinker who avoided caffeine because it made her “jittery.” She saw a mental health counselor on a twice a week basis. Physical exam was significant for sad affect with occasional crying. Patient moved slowly and with obvious discomfort. TOVA (Test of Variables of Attention) showed a significantly dysfunctional score of –7.43.
Neurology and Nutrition
Published in Mary J. Marian, Gerard E. Mullin, Integrating Nutrition Into Practice, 2017
Phosphatidylserine (PS) is one of several types of phospholipids that play critical roles in the nervous system, as a building block of neuron cell membrane structure as well as neurotransmitter production. Vaisman et al.74 conducted a double-blind trial investigating omega-3 with phosphatidylserine for ADHD. They recruited 60 children (3:1 ratio of boys:girls; average age 9 years) with ADHD symptoms who were subsequently randomized to three groups (1) canola oil (controls), (2) fish oil (providing 250 mg DHA/EPA daily), and (3) an omega-3/PS combination (providing 300 mg PS and 250 mg DHA/EPA daily). No stimulant medications or other dietary supplements were administered during the trial period (80–100 days; average 91 days). The group receiving PS and omega-3 had the highest proportion of children whose symptoms improved. The children’s sustained visual attention and discrimination were assessed using the Test of Variables of Attention (TOVA). This score improved for subjects over controls for both the omega-3 PS and the fish oil groups, but significantly more in the PS group (p < 0.001). This indicates that omega-3 PS improved attention performance (and more dramatically than fish oil) compared to the control group. Omega-3 PS ameliorated the inattention symptoms of ADHD to a greater degree than equivalent amounts of DHA/EPA from other dietary sources.74 Further, these results suggest that a lower dose of omega-3 fatty acids may achieve better outcome when bound to phospholipids, which also addresses such issues as overfishing and ocean conservation as well as patient cost for supplements. Another study investigated phosphatidylserine (200 mg/day vs. placebo) in 36 children ages 4–14 and found improvements in ADHD, inattention, and short-term auditory memory.75
Ready for a Learner’s Permit? Clinical Neuropsychological Off-road Tests and Driving Behaviors in a Simulator among Adolescents with ADHD and ASD
Published in Developmental Neurorehabilitation, 2021
H Selander, N Strand, M Almberg, B Lidestam
Some cognitive tests are considered more valuable and useful for screening patients and for guiding clinical practice when determining fitness to drive, such as the Useful Field of View (UFOV) test.17 The UFOV test is a PC-based visual and cognitive test of the visual field over which a person can process visual information, and the test performance relies on higher-order cognitive abilities as well as visual (sensory and perceptual) function.18 The UFOV test has been associated with driving competence in older drivers in numerous studies.19 Among older drivers, visual field loss from stroke is not uncommon, both diagnosed and undiagnosed. However, considerably less research has been done on this with regard to younger or novice drivers.20,21 Hypothetically and because of their reliance on higher-order cognitive processing, the functional impairments of ADHD related to attention, hyperactivity, inattention, and impulse control should be reflected in the performance in the UFOV test. The Test of Variables of Attention (TOVA) is a neuropsychological test of concentration, impulsivity, response time, speed of processing, and inattention.22,23 The TOVA has proven sensitive for identifying ADHD-like symptoms,23 but was not developed as a tool for fitness-to-drive assessment. However, on-road assessments cannot be included because the assessment needs to be completed before a learner’s permit is issued. For clinical practice, fitness-to-drive decisions may be challenging for this group of patients due to lack of guidelines, evidence, and test norms.
Randomised sham-controlled study of high-frequency bilateral deep transcranial magnetic stimulation (dTMS) to treat adult attention hyperactive disorder (ADHD): Negative results
Published in The World Journal of Biological Psychiatry, 2018
Yaniv Paz, Keren Friedwald, Yeheal Levkovitz, Abraham Zangen, Uri Alyagon, Uri Nitzan, Aviv Segev, Hagai Maoz, May Koubi, Yuval Bloch
Evaluations were performed at baseline; after the tenth session (only for Test of Variables of Attention (TOVA)); after the twentieth session (end-point); and a week after treatment completion (follow-up). Evaluations included Conners' Adult ADHD Rating Scale (CAARS) questionnaire (Rosler et al. 2010), a self-report commonly used to monitor ADHD symptomatology, and a computerised continuous performance test, the TOVA, which is often used to monitor therapeutic effects in ADHD (Manor et al. 2008).
The Efficacy of Cognitive Videogame Training for ADHD and What FDA Clearance Means for Clinicians
Published in Evidence-Based Practice in Child and Adolescent Mental Health, 2021
Steven W. Evans, Theodore P. Beauchaine, Andrea Chronis-Tuscano, Stephen P. Becker, Anil Chacko, Richard Gallagher, Cynthia M. Hartung, Michael J. Kofler, Brandon K. Schultz, Leanne Tamm, Eric A. Youngstrom
News that EndeavorRXTM CT received FDA clearance warrants close examination of scientific evidence supporting the intervention. Although Akili (the company that owns Endeavor) claims “rigorous” evaluation across various clinical trials, as of November 2020 none of these involved a randomized clinical trial that demonstrated treatment gains in ratings or other indices of symptoms or impairment (see https://www.akiliinteractive.com/news for research updates). The most comprehensive evaluation of EndeavorRXTM was a carefully designed RCT of youth (ages 8–12 years) with ADHD (Kollins et al., 2020). The RCT included preregistration at ClinicalTrials.gov, an active digital control group, double-blinded outcomes, and a large sample size (N = 348). Participants were to play the CT videogame at home, named AKL-T01 in the study (i.e., EndeavorRXTM), for five 5-min sessions per day 5 days per week for 4 weeks (actual sessions completed M = 83.2 out of 100 prescribed). Significant treatment gains were reported on the Test of Variables of Attention (TOVA; Leark et al., 2016; preregistered as primary outcome at ClinicalTrials.gov), a CPT, compared to participants in the control group. However, the treatment did not yield improvements in (a) parent-reported ADHD symptoms, as indexed by the ADHD-Rating Scale (ADHD-RS; DuPaul et al., 2016); or (b) parent- or clinician-reports of impairment, as indexed by the Impairment Rating Scale (IRS) and the Clinical Global Impressions (CGI). Lack of effects on these measures indicates that any changes in child behavior were undetectable by parents and clinicians. Nevertheless, Kollins et al. (2020) argued that the TOVA is “mimicking one component of the classroom situation in which children are required to remain seated and engaged in a tedious, repetitive task, suggesting ecological validity of the TOVA test for real-world settings in which children with ADHD often struggle” (p. e175). This conclusion warrants scrutiny because CPTs such as the TOVA are only weakly associated with observations of classroom attention (Rapport et al., 2009). In fact, observations of child behavior while completing a CPT predicts their classroom behavior better than CPT performance itself (Borger et al., 1999; Weis & Totten, 2004). Thus, it is unsurprising that small gains on the TOVA test failed to translate to changes in “real world” behavior in the RCT. Indeed, although near transfer to a laboratory measure (TOVA) was observed, far transfer to ADHD symptoms and impairment was not. Given that this was a meticulously designed RCT, lack of far transfer is noteworthy. Furthermore, effect sizes of near transfer were small. Although Kollins and colleagues did not report effect sizes, the TOVA data provided in the article indicate a Cohen’s d of 0.28. This indicates 92% overlap in posttest group distributions of TOVA scores for treated versus control participants. Changes this small, although detectable statistically, are not “visible to the naked eye of a careful observer” (Cohen, 1992, p. 156).