Cortical Correlates of Spatial Navigation Skills in an Immersive Virtual Reality Environment

NCT ID: NCT06710301

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to investigate the neural mechanisms that undergoes spatial navigation skills in children/adolescents aged between 8 and 17 years. These skills play an important role in daily life, as they allow us to orient ourselves in familiar and unfamiliar environments, locate objects, interact with them and memorize their position. Navigation abilities vary widely between individuals, change with age and might be affected by diseases, such as the cerebral palsy (CP). Previous studies have, in fact, demonstrated differences in the learning and adaptation methods of spatial navigation skills in children affected by CP compared to typically developing (TD) peers. Through the use of the electroencephalogram (EEG) we want to shed light on the mechanisms that govern this ability with the aim of:

1. better characterize spatial navigation skills in children/adolescents, both TD and affected by CP;
2. investigate the origin of the differences found between the spatial navigation skills of TD children and those affected by CP, improving knowledge of the pathology and thus allowing, in the future, to identify more adequate rehabilitation interventions.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy (CP)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Navigation skills EEG Virtual Reality Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Navigation task

Administration of the navigation task in an immersive virtual reality environment with recording of the EEG signal

Group Type EXPERIMENTAL

Preliminary assessment

Intervention Type OTHER

Evaluation of the cognitive level through the Raven test and of spatial navigation skills through the Corsi test and the maze sub-test of the WISC-III.

Navigation task with EEG recording

Intervention Type OTHER

Administration of the navigation task in an immersive virtual reality environment and EEG signal recording. The participant will wear virtual reality viewers and EEG cap. The task consists in moving and orienting themselves inside a five-way maze in order to reach a treasure. The participant will be asked to carry out 30 trials lasting a maximum of 120s each.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Preliminary assessment

Evaluation of the cognitive level through the Raven test and of spatial navigation skills through the Corsi test and the maze sub-test of the WISC-III.

Intervention Type OTHER

Navigation task with EEG recording

Administration of the navigation task in an immersive virtual reality environment and EEG signal recording. The participant will wear virtual reality viewers and EEG cap. The task consists in moving and orienting themselves inside a five-way maze in order to reach a treasure. The participant will be asked to carry out 30 trials lasting a maximum of 120s each.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* typically developing subjects aged between 8 and 17 years;
* subjects with CP aged between 8 and 17 years;

Exclusion Criteria

* subjects aged under 8 or over 17 years;
* subjects with epileptic problems;
* subjects with poor head control;
* subjects with visual problems that can not be corrected with prescription lens;
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS Scientific Institute E. Medea

Bosisio Parini, LC, Italy

Site Status RECRUITING

IRCCS Scientific Institute E. Medea

Conegliano, TV, Italy

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Emilia Biffi

Role: CONTACT

Phone: +39031877862

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Emilia Biffi

Role: primary

Caterina Piazza

Role: backup

Susanna Paterlini

Role: primary

Francesca Oppia

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1111

Identifier Type: -

Identifier Source: org_study_id