Cerebral Palsy (CP)NCT06710301
Cortical Correlates of Spatial Navigation Skills in an Immersive Virtual Reality Environment
A study testing Preliminary assessment and Navigation task with EEG recording in people with Cerebral Palsy (CP), run by IRCCS Eugenio Medea at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Preliminary assessment and Navigation task with EEG recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 14 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- typically developing subjects aged between 8 and 17 years;
- subjects with CP aged between 8 and 17 years;
Who cannot join
- 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;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Scientific Institute E. Medea
Bosisio Parini, LC, 23842
Emilia Biffi, +39031877862, emilia.biffi@lanostrafamiglia.it
Caterina Piazza, +39031877862, caterina.piazza@lanostrafamiglia.it
- Recruiting
IRCCS Scientific Institute E. Medea
Conegliano, TV, 31015
Susanna Paterlini, +3904384141, susanna.paterlini@lanostrafamiglia.it
Francesca Oppia, +3904384141, francesca.oppia@lanostrafamiglia.it
About this study
Official title: 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Preliminary assessment, Navigation task with EEG recording
- Keywords
- Navigation skills, EEG, Virtual Reality, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preliminary assessmentOther
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 recordingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Navigation task | Experimental | Administration of the navigation task in an immersive virtual reality environment with recording of the EEG signal Receives: Other: Preliminary assessment; Other: Navigation task with EEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power Spectral Density (PSD)
Differences in power values between TD and CP subjects
Measured: 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.
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start14 Nov 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710301
- Sponsor's protocol ID
- 1111
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Cortical Correlates of Spatial Navigation Skills in an Immersive Virtual Reality Environment
- ClinicalTrials.gov ID
- NCT06710301
- Acronym / sponsor ID
- 1111
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Navigation skills, EEG, Virtual Reality, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navigation task | Experimental | Other: Preliminary assessment, Other: Navigation task with EEG recordingAdministration of the navigation task in an immersive virtual reality environment with recording of the EEG signal |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- typically developing subjects aged between 8 and 17 years;
- subjects with CP aged between 8 and 17 years;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preliminary assessmentEvaluation 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. | Other | Navigation task |
| Navigation task with EEG recordingAdministration 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. | Other | Navigation task |
Primary outcome
Power Spectral Density (PSD)
Time frame: Once
Differences in power values between TD and CP subjects
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preliminary assessment and Navigation task with EEG recording in people with Cerebral Palsy (CP), run by IRCCS Eugenio Medea at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilia Biffi (+39031877862, emilia.biffi@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power Spectral Density (PSD) (time frame: Once). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.