EWM Training for ADHD

Overseen By Abigail Sullivan, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Hartford Hospital

Disqualifiers: Psychosis, Bipolar, ASD, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

130 Participants Needed

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. ^{1 2 3 4 5}

Is EWM Training for ADHD safe for humans?

The research articles reviewed do not provide specific safety data for EWM Training or similar interventions like placebo treatments in ADHD. They focus on the effects of placebo in ADHD treatment but do not address safety concerns directly. ^{6 7 8 9 10}

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. ^{1 2 5 11 12}

Research Team

Michael C Stevens, PhD

Principal Investigator

Institute of Living/Hartford Hospital

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

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.

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
• Placebo Training

Trial Overview The 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

Group I: ADHD EWM Experimental Treatment 1 Intervention

Participants will receive EWM training sessions.

Group II: ADHD Placebo Placebo Group 1 Intervention

Participants will receive placebo training sessions.

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Findings from Research

Cogmed Working Memory Training (CWMT) significantly improved short-term memory performance in children with ADHD on tasks similar to the training activities, compared to a placebo group.

However, CWMT did not lead to improvements in broader ADHD symptoms, such as attentional problems, impulsivity, or academic performance in reading, spelling, comprehension, or mathematics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary: Working memory training and ADHD - where does its potential lie? Reflections on Chacko et al. (2014). Gathercole, SE.[2022]

A study involving 67 children with ADHD showed that a 25-day computerized working memory training program led to significant long-term improvements in working memory tasks, particularly in the visual domain.

The training resulted in lasting gains in performance across various working memory measures, suggesting that targeted interventions can be effective for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RCT of working memory training in ADHD: long-term near-transfer effects. Hovik, KT., Saunes, BK., Aarlien, AK., et al.[2021]

In a study involving 14 children with Attention Deficit Disorder with Hyperactivity (ADD + H), methylphenidate significantly improved verbal memory and learning compared to placebo, with effects increasing with higher doses.

The drug specifically enhanced the storage and retrieval of information rather than the immediate acquisition of new information, indicating a targeted mechanism of action in improving memory functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methylphenidate and memory: dissociated effects in hyperactive children. Evans, RW., Gualtieri, CT., Amara, I.[2019]

The study involved 30 children with ADHD who underwent working memory training, showing significant improvements in working memory and inhibitory control after the intervention.

The Active Memory Intervention (AMIN) not only enhanced cognitive functions but also reduced ADHD symptoms in both home and school settings, indicating its effectiveness as a transferable intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of comprehensive working memory training on executive functions and behavioral symptoms in children with attention deficit-hyperactivity disorder (ADHD). Nejati, V., Derakhshan, Z., Mohtasham, A.[2023]

In a study of 24 adults with ADHD, 66.67% completed a 25-session computerized working memory training program, indicating good feasibility and acceptability in a psychiatric outpatient setting.

Preliminary results showed that participants experienced fewer cognitive difficulties and improved neuropsychological performance after training, suggesting that this intervention may be effective and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized working memory training for adults with ADHD in a psychiatric outpatient context-a feasibility trial. Sjöwall, D., Berglund, M., Hirvikoski, T.[2023]

In a study of 118 children with attention deficit disorder (ADD), three distinct response types to methylphenidate were identified: 'responders' who improved significantly on medication, 'nonresponders' who showed little change on both medication and placebo, and 'placebo responders' who improved on placebo similarly to responders on medication.

The presence of 'placebo responders' (18% of the group) highlights the importance of double-blind placebo-controlled evaluations in ADD treatment, as it helps prevent unnecessary medication for children who may only be experiencing nonspecific effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responders, nonresponders, and placebo responders among children with attention deficit disorder. Importance of a blinded placebo evaluation. Ullmann, RK., Sleator, EK.[2017]

A meta-analysis of 128 randomized controlled trials involving over 19,000 participants revealed significant placebo effects on the efficacy of ADHD medications, indicating that non-specific factors can influence treatment outcomes.

While ADHD medications are more effective than placebo, the study highlights the importance of understanding and potentially incorporating placebo-related factors into clinical practice to enhance treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in randomised, controlled trials of medications for ADHD: a systematic review and meta-analysis. Faraone, SV., Newcorn, JH., Cipriani, A., et al.[2022]

In a study involving normal adult males, magnesium pemoline (25 or 37.5 mg) was found to be less effective than a placebo in various learning and memory tests, indicating potential ineffectiveness as a cognitive enhancer.

The study included tests for verbal learning, motor learning, and memory retention, but the only significant finding was that those taking pemoline performed worse than those taking the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium pemolone: lack of facilitation in human learning, memory, and performance tests. Smith, RG.[2019]

A systematic review of 8 studies involving 393 children with ADHD found that methylphenidate (MPH) significantly reduces daytime activity levels compared to placebo, indicating its efficacy in managing hyperactivity.

However, the use of MPH was associated with a significant decrease in total sleep time, suggesting a potential adverse effect on sleep patterns in children undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of actigraphy in the monitoring of methylphenidate versus placebo in ADHD: a meta-analysis. De Crescenzo, F., Armando, M., Mazzone, L., et al.[2014]

In a study involving 540 children with ADHD, a significant placebo response was observed, with parents reporting a greater improvement (10.57 points) compared to teachers (3.93 points), highlighting the influence of observer perspective on treatment outcomes.

Various psychosocial factors, such as income and education for parents, and ethnicity for teachers, were found to affect the magnitude of the placebo response, suggesting that these factors should be considered in clinical trial designs and interpretations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response and its determinants in children with ADHD across multiple observers and settings: A randomized clinical trial. Fageera, W., Traicu, A., Sengupta, SM., et al.[2021]

Cognitive training, specifically Cogmed Working Memory Training and 'Paying Attention in Class,' can be beneficial for children with ADHD, but the effectiveness varies based on individual factors like ADHD subtype and comorbid conditions.

Initial cognitive abilities, such as verbal and visual working memory skills, primarily influence near transfer outcomes, while parent and teacher ratings of executive functioning are more affected by the subtype of ADHD, suggesting that personalized approaches may enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and Moderators of Treatment Outcome in Cognitive Training for Children With ADHD. van der Donk, MLA., Hiemstra-Beernink, AC., Tjeenk-Kalff, AC., et al.[2021]

A study involving 53 children with ADHD demonstrated that computerized training of working memory (WM) significantly improved WM performance, as well as response inhibition and reasoning skills, both immediately after training and at a 3-month follow-up.

Parents reported a significant reduction in symptoms of inattention and hyperactivity/impulsivity in their children after the WM training, indicating that this intervention may effectively address key challenges associated with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized training of working memory in children with ADHD--a randomized, controlled trial. Klingberg, T., Fernell, E., Olesen, PJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Commentary: Working memory training and ADHD - where does its potential lie? Reflections on Chacko et al. (2014). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

RCT of working memory training in ADHD: long-term near-transfer effects. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Methylphenidate and memory: dissociated effects in hyperactive children. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of comprehensive working memory training on executive functions and behavioral symptoms in children with attention deficit-hyperactivity disorder (ADHD). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Computerized working memory training for adults with ADHD in a psychiatric outpatient context-a feasibility trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Responders, nonresponders, and placebo responders among children with attention deficit disorder. Importance of a blinded placebo evaluation. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in randomised, controlled trials of medications for ADHD: a systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Magnesium pemolone: lack of facilitation in human learning, memory, and performance tests. [2019]

9. Austria pubmed.ncbi.nlm.nih.gov

The use of actigraphy in the monitoring of methylphenidate versus placebo in ADHD: a meta-analysis. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Placebo response and its determinants in children with ADHD across multiple observers and settings: A randomized clinical trial. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Predictors and Moderators of Treatment Outcome in Cognitive Training for Children With ADHD. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Computerized training of working memory in children with ADHD--a randomized, controlled trial. [2022]