RECOGNeyes Gaze-Control Training

NCT06691646 | Completed

• 1 other identifier: CiC2017026
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

RECOGNeyes is a computer game developed by members of the research team to improve attention in people who find it hard to "keep their eyes on the task". Players use a small eyetracker to control the game with their eyes, giving their gaze-control system (oculomotor control system) a thorough work-out. This is a "confidence-in-concept" study to see whether RECOGNeyes holds promise as an approach to improving attentional control. It takes the form of a clinical trial, in which three groups of participants will undertake different amounts of RECOGNeyes training. The goals of the study are to find out:

• Whether RECOGNeyes training changes patterns of brain activity during a challenging gaze-control task.
• What changes in brain activity participants show when their gaze control improves. Before and after RECOGNeyes training, participants will have two kinds of brain scan:
• Magnetoencephalography to measure their brain waves while they do a gaze-control task that involves shifting their gaze to look either towards, or away from, an object that suddenly appears on the left or right side of a screen. It takes extra control to look away from the object as they have to actively resist the strong impulse to look towards it.
• Functional magnetic resonance imaging of the brain while the participants are at rest in the scanner, with their eyes open. This reveals the connection patterns between different parts of the brain when the participant is not doing anything in particular.
• Measure changes in brain waves and brain connectivity before and after training.
• Measure improvements in the gaze-control task and how strongly the improvements relate to brain changes.
• See whether the brain changes relate to how long the participants spent training. If participants who trained for longer show more improved gaze control, as well as greater brain changes, this will provide grounds for confidence in the RECOGNeyes approach to improving inattention.

Conditions

Inattention; Cognitive Training; Cognitive Control; Oculomotor Dysfunction; Magnetoencephalography (MEG)

Keywords

gaze-control training; oculomotor control; attention deficit/hyperactivity disorder (ADHD); magnetoencephalography; dyslexia/reading disorder; resting state brain connectivity

Outcome Measures

Primary Outcomes (3)

• Change in strength of alpha-beta oscillatory coupling

  Change in strength of coupling between beta amplitude in right dorsolateral prefrontal cortex and high alpha amplitude in frontal eyefields during the cue-target period on anti-saccade trials, relative to prosaccade trials.

  From enrolment day visit to second visit following two weeks gaze-control training.

• Change in beta-band oscillatory amplitude in dorsolateral pre-frontal cortex

  Changes in beta-band (13-30 Hz) ERSP during the cue-target period of anti-saccade trials, relative to prosaccade trials.

  From enrolment day visit to second visit following two weeks gaze-control training.

• Changes in alpha-band oscillatory amplitude in frontal eyefields

  Changes in alpha-band (8-12 hz) ERSP during the cue-target period on anti-saccade trials, relative to prosaccade trials.

  From enrolment day visit to second visit following two weeks gaze-control training.

Secondary Outcomes (5)

• Changes in degree of post-stimulus beta desynchronisation and synchronisation

  From enrolment day visit to second visit following two weeks gaze-control training.

• Changes in antisaccade task performance

  From enrolment day visit to second visit following two weeks gaze-control training.

• Changes in event-related pupil dilation and vergence rates

  From enrolment day visit to second visit following two weeks gaze-control training.

• Changes in tonic pupil diameter and vergence

  From enrolment day visit to second visit following two weeks gaze-control training.

• Changes in single word reading efficiency

  From enrolment day visit to second visit following two weeks gaze-control training.

Other Outcomes (2)

• Changes in eye-movment patterns during reading

  From enrolment day visit to second visit following two weeks gaze-control training.

• Changes in resting state brain connectivity

  From enrolment day visit to second visit following two weeks gaze-control training.

Study Arms (3)

Two training sessions per week

EXPERIMENTAL

Train with RECOGNeyes gaze training game at home twice a week, for between 20 to 30 minutes per training session, for two weeks.

Behavioral: Gaze-control training game

Three training sessions per week

EXPERIMENTAL

Train with RECOGNeyes gaze training game at home three times per week, for between 20 to 30 minutes per training session, for two weeks.

Behavioral: Gaze-control training game

Four training sessions per week

EXPERIMENTAL

Train with RECOGNeyes gaze training game at home four times per week, for between 20 to 30 minutes per training session, for two weeks.

Behavioral: Gaze-control training game

Interventions

Gaze-control training game BEHAVIORAL

An eyetracker-controlled computer game designed to improve attentional control by training inhibitory control over direction of gaze. It includes six mini-games, each designed to train different aspects of oculomotor control, including selective attention, motor inhibition, motor timing, and spatial working memory.

Also known as: RECOGNeyes

Four training sessions per week; Three training sessions per week; Two training sessions per week

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range 18-30 years
• Ability to give informed consent
• We will prioritise recruiting volunteers who have ADHD, dyslexia, dyspraxia or dyscalculia
• Normal or corrected-to-normal vision

You may not qualify if:

• Partial sight or visual field deficit

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Faculty of Medicine and Health Sciences, University of Nottingham, Queen's Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (5)

• Braun V, Clarke, V:Using thematic analysis in psychology. Qualitative Research in Psychology. 2006 3:2, 77-101.

  BACKGROUND

• Hwang K, Ghuman AS, Manoach DS, Jones SR, Luna B. Frontal preparatory neural oscillations associated with cognitive control: A developmental study comparing young adults and adolescents. Neuroimage. 2016 Aug 1;136:139-48. doi: 10.1016/j.neuroimage.2016.05.017. Epub 2016 May 10.

  PMID: 27173759 BACKGROUND

• Hwang K, Ghuman AS, Manoach DS, Jones SR, Luna B. Cortical neurodynamics of inhibitory control. J Neurosci. 2014 Jul 16;34(29):9551-61. doi: 10.1523/JNEUROSCI.4889-13.2014.

  PMID: 25031398 BACKGROUND

• Goldberg DP, Williams P: A user's guide to the General Health Questionnaire. 1988, Basingstoke NFER-Nelson

  BACKGROUND

• Conners CK, Ehrhard D, Sparrow D. CAARS Adult ADHD Rating Scales. New York: Multi-Health Systems; 1999.

  BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Dyslexia

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth B Liddle, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All researchers involved in data collection are masked until after data collection and preprocessing is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Translational Mental Health

Model Details: Participants randomly assigned to undertake 2, 3 or 4 training sessions at home, per week, for 20 to 30 minutes per session over a period of two weeks. Total achieved training time is recorded and will be correlated with outcomes.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: May 4, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)