NCT06710301

Brief Summary

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. 1.better characterize spatial navigation skills in children/adolescents, both TD and affected by CP;
  2. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Nov 2024Dec 2026

Study Start

First participant enrolled

November 14, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

November 25, 2024

Last Update Submit

November 18, 2025

Conditions

Keywords

Navigation skillsEEGVirtual RealityCerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • Power Spectral Density (PSD)

    Differences in power values between TD and CP subjects

    Once

  • Navigation performance

    Navigation performance based on the following parameters: number of routes visited in each trial; total length of the path for each trial; error between distance traveled and ideal distance for each trial (identified as the minimum distance to reach the treasure from the starting point); angle of rotation of the viewer in each trial; duration of each trial.

    Once

Study Arms (1)

Navigation task

EXPERIMENTAL

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

Other: Preliminary assessmentOther: Navigation task with EEG recording

Interventions

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

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.

Navigation task

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS Scientific Institute E. Medea

Bosisio Parini, LC, 23842, Italy

RECRUITING

IRCCS Scientific Institute E. Medea

Conegliano, TV, 31015, Italy

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 29, 2024

Study Start

November 14, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations