- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06710301
Cortical Correlates of Spatial Navigation Skills in an Immersive Virtual Reality Environment
Study of the Cortical Correlates of Spatial Navigation Skills in an Immersive Virtual Reality Environment
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:
- better characterize spatial navigation skills in children/adolescents, both TD and affected by CP;
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emilia Biffi
- Phone Number: +39031877862
- Email: emilia.biffi@lanostrafamiglia.it
Study Locations
-
-
LC
-
Bosisio Parini, LC, Italy, 23842
- Recruiting
- IRCCS Scientific Institute E. Medea
-
Contact:
- Emilia Biffi
- Phone Number: +39031877862
- Email: emilia.biffi@lanostrafamiglia.it
-
Contact:
- Caterina Piazza
- Phone Number: +39031877862
- Email: caterina.piazza@lanostrafamiglia.it
-
-
TV
-
Conegliano, TV, Italy, 31015
- Recruiting
- IRCCS Scientific Institute E. Medea
-
Contact:
- Susanna Paterlini
- Phone Number: +3904384141
- Email: susanna.paterlini@lanostrafamiglia.it
-
Contact:
- Francesca Oppia
- Phone Number: +3904384141
- Email: francesca.oppia@lanostrafamiglia.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Navigation task
Administration of the navigation task in an immersive virtual reality environment with recording of the EEG signal
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Power Spectral Density (PSD)
Time Frame: Once
|
Differences in power values between TD and CP subjects
|
Once
|
|
Navigation performance
Time Frame: Once
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1111 (Other Grant/Funding Number: Prima Psychiatry internal research fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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