Search Task Strategies for Attention

Overseen By Cailey Tennyson, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Vision less than 20/25, neuromuscular or visual disorders

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal is to look for qualitative differences in visual search behavior when one search is performed many times in a row compared to when multiple search tasks are intermixed. Four search tasks are tested. The target is the same in every task but the types of distractors change from task to task. In the Mixed condition, the four tasks are randomly changed from trial to trial. In the Blocked condition, each task is run as a block of 100 trials.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to ask the trial organizers for more details.

What safety data exists for the treatment evaluated under different names like Blocked Trials and Mixed Trials?

The research articles discuss methods for analyzing adverse events in clinical trials, including serious events, but do not provide specific safety data for the treatment in question. They focus on statistical methods and systems for monitoring drug safety rather than specific safety outcomes for this treatment. ^{1 2 3 4 5}

How does the treatment 'Blocked Trials, Mixed Trials' for attention differ from other treatments?

This treatment is unique because it involves different strategies for visual search tasks, using either blocked or mixed trials to manage attention. Blocked trials allow for a consistent approach, while mixed trials require quick adaptation to changing conditions, highlighting the flexibility and efficiency of attention mechanisms. ^{6 7 8 9 10}

Research Team

Jeremy M Wolfe, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is suitable for individuals with normal vision and attention spans, as well as those diagnosed with Attention Deficit Disorder. Participants should be able to perform visual search tasks repeatedly. There are no specific inclusion or exclusion criteria provided.

Inclusion Criteria

Pass Ishihara color vision test

Exclusion Criteria

Vision less than 20/25 with correction

History of neuromuscular or visual disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Observers are trained on four different search tasks with varying distractors

2 weeks

Experimentation

Participants perform 400 trials in both Mixed and Blocked conditions

4 weeks

Follow-up

Participants are monitored for response time and accuracy after experimentation

4 weeks

Treatment Details

Interventions

• Blocked Trials
• Mixed trials

Trial Overview The study examines differences in visual search behavior by comparing 'Blocked Trials' where one task is repeated 100 times, against 'Mixed Trials' where four different tasks are randomly intermixed during the trials.

Participant Groups

Group I: Mixed Trials Experimental Treatment 1 Intervention

There are four search tasks in this experiment. All tasks will be randomly mixed in a single block of 400 trials.

Group II: Blocked Trials Experimental Treatment 1 Intervention

There are four search tasks in this experiment. Each task will be presented in a separate block of 100 trials

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Findings from Research

The FDA recommends that sponsors create a Safety Surveillance Plan to systematically monitor safety data, suggesting two methods: analyzing serious adverse events (SAEs) by treatment group or using a trigger rate for unblinded analysis if SAEs exceed expected background rates.

The article introduces a procedural workflow for a blinded review of safety data, utilizing the Bayesian detection method (BDRIBS) to quantitatively assess risks, and provides tools for visualizing and analyzing safety data across multiple studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Bayesian detection of potential risk using inference on blinded safety data (BDRIBS) method to support the decision to refer an event for unblinded evaluation. Waterhouse, B., Hartford, A., Mukhopadhyay, S., et al.[2022]

The FDA Adverse Event Reporting System (FAERS) is crucial for monitoring drug safety, but there has been a lack of systematic methods to compare adverse event rates across different drugs.

The study introduces a new statistical method that can effectively identify significant differences in adverse event rates among drugs while also estimating variations in age and gender distributions, enhancing the understanding of drug safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Different Adverse Effects Among Multiple Drugs Using FAERS Data. Huang, J., Zhang, X., Du, J., et al.[2021]

In 2011, the MedWatch system received 600,000 adverse event reports, highlighting its role in improving drug and device safety awareness, but it also faces challenges with reporting bias and data accuracy.

A study analyzing 10.2 million reports found that while patient information was mostly accurate, suspect product data was often incomplete or incorrect, with significant gaps in key details like dosage and product lot numbers, which could lead to incorrect conclusions about drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the completeness and accuracy of MedWatch data. Getz, KA., Stergiopoulos, S., Kaitin, KI.[2017]

References

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

Statistical analyses of adverse event data from clinical trials. Special emphasis on serious events. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Using the Bayesian detection of potential risk using inference on blinded safety data (BDRIBS) method to support the decision to refer an event for unblinded evaluation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Detecting potential safety issues in large clinical or observational trials by Bayesian screening when event counts arise from poisson distributions. [2015]

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

Comparing Different Adverse Effects Among Multiple Drugs Using FAERS Data. [2021]

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

Evaluating the completeness and accuracy of MedWatch data. [2017]

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

Combining attention: a novel way of conceptualizing the links between attention, sensory processing, and behavior. [2019]

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

The attention operating characteristic: examples from visual search. [2019]

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

A taxonomy of external and internal attention. [2010]

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

Stimulus-determined discrimination mechanisms for color search. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Attention-Setting and Human Mental Function. [2022]