Trial Summary
What is the purpose of this trial?
The proposed study will replicate target engagement as assessed in the first phase while also determining if it correlates with clinically meaningful improvements in ADHD dysfunction
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the EWM Training treatment for ADHD?
Some studies suggest that working memory training can improve working memory and inhibitory control in children with ADHD, and may help reduce ADHD symptoms at home and school. However, other research indicates that while working memory training can enhance short-term memory tasks, it may not significantly improve classic ADHD symptoms like attention problems or impulsivity.12345
Is EWM Training for ADHD safe for humans?
How is EWM Training different from other ADHD treatments?
EWM Training is unique because it focuses on improving working memory through computerized exercises, which is different from traditional ADHD treatments that often involve medication or behavioral therapy. This approach aims to enhance cognitive skills by practicing memory tasks that gradually increase in difficulty.1251112
Eligibility Criteria
This trial is for individuals diagnosed with ADHD. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.Inclusion Criteria
Diagnosis of ADHD
English speaking
Right-handed
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Exclusion Criteria
I have a brain condition or neurological disorder.
Braces, metal, or implant devices
I have had a traumatic brain injury or was unconscious for over 30 minutes.
See 1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo executive working memory (EWM) training or placebo sessions 4 times each week for 5 weeks
5 weeks
Remote sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in fMRI measurements and performance on cognitive tasks
4 weeks
Treatment Details
Interventions
- EWM Training (Behavioral Intervention)
- Placebo Training (Behavioral Intervention)
Trial OverviewThe study is testing a training called EWM Training against a Placebo Training to see if it helps improve executive working memory and reduces symptoms of ADHD.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ADHD EWMExperimental Treatment1 Intervention
Participants will receive EWM training sessions.
Group II: ADHD PlaceboPlacebo Group1 Intervention
Participants will receive placebo training sessions.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Institute of Living/Hartford HospitalHartford, CT
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Who Is Running the Clinical Trial?
Hartford HospitalLead Sponsor
References
Commentary: Working memory training and ADHD - where does its potential lie? Reflections on Chacko et al. (2014). [2022]Chacko et al.'s investigation of the clinical utility of WM training to alleviate key symptoms of ADHD is timely and substantial, and marks a significant point in cognitive training research. Cogmed Working Memory Training (CWMT) involves intensive practice on multiple memory span tasks that increase in difficulty as performance improves with practice. Relative to a placebo version in which the span level of the memory tasks are kept at a low fixed level, Chacko et al. () found that CWMT boosted the performance of children with ADHD on short-term memory (STM) tasks similar to trained activities. Complex WM span measures sharing little overlap with the structure of training activities were not enhanced. Neither did active CWMT ameliorate classic symptoms of ADHD such as parent or teacher ratings of attentional problems, or direct measures of motor impulsivity and sustained attention. Reading, spelling, comprehension or mathematics scores similarly showed no response to training.
RCT of working memory training in ADHD: long-term near-transfer effects. [2021]The aim of the study is to evaluate the long-term near-transfer effects of computerized working memory (WM) training on standard WM tasks in children with Attention-Deficit/Hyperactivity Disorder (ADHD).
Methylphenidate and memory: dissociated effects in hyperactive children. [2019]Fourteen children with Attention Deficit Disorder with Hyperactivity (ADD + H) were administered the psychostimulant methylphenidate in a double-blind, placebo-controlled, crossover study. Subjects were evaluated on a well-validated measure of verbal memory and learning with an experimental design comprised of four conditions: placebo and active drug at three doses. Positive memory effects were found in the drug conditions. Significant dose-response relationships were found, indicating enhanced learning from placebo to low to medium to high dose. However, there was a differential drug effect on the memory task; methylphenidate selectively enhanced storage and retrieval mechanisms without affecting immediate acquisition.
The effect of comprehensive working memory training on executive functions and behavioral symptoms in children with attention deficit-hyperactivity disorder (ADHD). [2023]This study aimed to evaluate the effect of working memory training on executive functions and behavioral symptoms in children with ADHD. Thirty children with ADHD were randomly assigned to active control or Active Memory Intervention (AMIN) group. Executive functions and rating scales were used for assessment in three baseline, post-intervention, and 1-month follow-up sessions. The results show AMIN improves working memory and inhibitory control as well as ameliorates ADHD symptoms at home and school. Working memory training is beneficial and transferable intervention in children with ADHD.
Computerized working memory training for adults with ADHD in a psychiatric outpatient context-a feasibility trial. [2023]This study investigated the feasibility (treatment completion, and acceptability) and preliminary effectiveness of computerized working memory (WM) training in a psychiatric outpatient context for adults with ADHD. Self-ratings, neuropsychological tests, and clinician's assessments were performed pre- and post-Cogmed WM training, as well as at the 2-month follow-up, which included 24 (age M = 36.75 SD = 8.37) participants. Of the 24 participants, 16 (66.67%) completed the 25 sessions within 7 weeks. Completers reported high treatment credibility, but a few spontaneously reported feeling stressed because of the time-consuming nature of the WM training (n = 4). Preliminary effectiveness analyses indicate fewer cognitive difficulties and increased neuropsychological performance in non-trained tests that remained stable at follow-up. Future development of WM training paradigms could investigate ways of making the perception of training experience less demanding regarding being time-consuming. The indication of preliminary effectiveness merits further randomized controlled studies in a clinical context.
Responders, nonresponders, and placebo responders among children with attention deficit disorder. Importance of a blinded placebo evaluation. [2017]The responses to methylphenidate of 118 children with attention deficit disorder (ADD) were studied under double-blind conditions. Three distinct types of response to medication and placebo were found, as determined by teacher ratings. One group, called "responders," improved dramatically in attention and hyperactivity ratings on active medication but showed essentially no change from baseline when on placebo. The group called "nonresponders" showed minimal change in ratings on either placebo or medication. The third group, "placebo responders," showed almost as much improvement as the responders on medication, but their ratings were not very different from medication ratings during the placebo trial. The placebo responders, 18 percent of the group, would have been considered responders in a nonplacebo-controlled study. Double-blind placebo evaluation of ADD children can and should be done by practitioners to avoid medicating children who are responding to nonspecific effects of drugs.
Placebo and nocebo responses in randomised, controlled trials of medications for ADHD: a systematic review and meta-analysis. [2022]The nature and magnitude of placebo and nocebo responses to ADHD medications and the extent to which response to active medications and placebo are inter-correlated is unclear. To assess the magnitude of placebo and nocebo responses to ADHD and their association with active treatment response. We searched literature until June 26, 2019, for published/unpublished double-blind, randomised placebo-controlled trials (RCTs) of ADHD medication. Authors were contacted for additional data. We assessed placebo effects on efficacy and nocebo effects on tolerability using random effects meta-analysis. We assessed the association of study design and patient features with placebo/nocebo response. We analysed 128 RCTs (10,578 children/adolescents and 9175 adults) and found significant and heterogenous placebo effects for all efficacy outcomes, with no publication bias. The placebo effect was greatest for clinician compared with other raters. We found nocebo effects on tolerability outcomes. Efficacy outcomes from most raters showed significant positive correlations between the baseline to endpoint placebo effects and the baseline to endpoint drug effects. Placebo and nocebo effects did not differ among drugs. Baseline severity and type of rating scale influenced the findings. Shared non-specific factors influence response to both placebo and active medication. Although ADHD medications are superior to placebo, and placebo treatment in clinical practice is not feasible, clinicians should attempt to incorporate factors associated with placebo effects into clinical care. Future studies should explore how such effects influence response to medication treatment. Upon publication, data will be available in Mendeley Data: PROSPERO (CRD42019130292).
Magnesium pemolone: lack of facilitation in human learning, memory, and performance tests. [2019]Either a placebo or 25 or 37.5 milligrams of magnesium pemoline was administered on a doubleblind basis to three intelligencematched groups of normal, adult males. Learning and 24-hour retention tests included verbal learning, motor learning, and classical conditioning. Short-term memory tests were administered through both the visual and auditory modalities. Arm-hand steadiness and visual reaction time performance tests were included. The only measures revealing significant group differences showed the performance of subjects given pemoline was inferior to that of subjects given a placebo.
The use of actigraphy in the monitoring of methylphenidate versus placebo in ADHD: a meta-analysis. [2014]Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood. There is an increasing need to find objective measures and markers of the disorder in order to assess the efficacy of the therapy and to improve follow-up strategies. Actigraphy is an objective method for recording motor activity and sleep parameters using small, computerized, watch-like devices worn on the body, and it has been used in many clinical trials to assess methylphenidate efficacy and adverse effects in ADHD. Our article aim is to systematically review and perform a meta-analysis of the current evidence on the role of actigraphy in both the detection of changes in activity and in sleep patterns in randomized clinical trials that compared methylphenidate against placebo in the treatment of ADHD. A comprehensive literature search of PubMed/MEDLINE, Scopus, Embase, Cochrane Library, CINHAL and PsycINFO databases was carried out to find randomized clinical trials comparing methylphenidate versus placebo in children with ADHD, using actigraphic measures as an outcome. No start date limit was used and the search was updated until June 2013. The primary outcome measures were 'total sleep time' and daytime 'activity mean'. As secondary outcomes, we analyzed 'sleep onset latency', 'sleep efficiency' and 'wake after sleep onset'. Eight articles comprising 393 patients were included in the analysis. Children with ADHD using MPH compared to placebo have a significant difference of a large effect with a diminishing value in the activity mean. For the total sleep time, we found a significant and large effect in the decrease in sleep in MPH group. This study shows that MPH may effectively reduce mean activity in ADHD children, but it may negatively affect total sleep time.
Placebo response and its determinants in children with ADHD across multiple observers and settings: A randomized clinical trial. [2021]This study aims to quantify placebo response (PR) in children with attention deficit hyperactivity disorder (ADHD) as assessed by parents and teachers and to explore some of its determinants. Five hundred and forty children with ADHD (ages 6-12) were recruited to a randomized, double-blind, placebo-controlled crossover trial with methylphenidate. The main outcome variable was Conners' Global Index (CGI), based on assessment of behaviour by parents (CGI-P) and teacher (CGI-T). PR was calculated as the difference between CGI-P/T scores at baseline and placebo week. There was a highly significant PR as assessed by the parents' and teachers' (p
Predictors and Moderators of Treatment Outcome in Cognitive Training for Children With ADHD. [2021]Objective: To explore whether clinical variables and initial cognitive abilities predict or moderate (far) transfer treatment outcomes of cognitive training. Method: A total of 98 children (aged 8-12 years) with ADHD were randomly assigned to Cogmed Working Memory Training or a new cognitive training called "Paying Attention in Class." Outcome measures included neurocognitive assessment, parent and teacher rated questionnaires of executive functioning behavior and academic performance. Predictor/moderator variables included use of medication, comorbidity, subtype of ADHD, and initial verbal and visual working memory skills. Results: Parent and teacher ratings of executive functioning behavior were predicted and moderated by subtype of ADHD. Word reading accuracy was predicted by subtype of ADHD and comorbidity. Use of medication and initial verbal and visual spatial working memory skills only predicted and moderated near transfer measures. Conclusion: Cognitive training can be beneficial for certain subgroups of children with ADHD; individual differences should be taken into account in future trials.
Computerized training of working memory in children with ADHD--a randomized, controlled trial. [2022]Deficits in executive functioning, including working memory (WM) deficits, have been suggested to be important in attention-deficit/hyperactivity disorder (ADHD). During 2002 to 2003, the authors conducted a multicenter, randomized, controlled, double-blind trial to investigate the effect of improving WM by computerized, systematic practice of WM tasks.