Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06474871

Virtual Reality vs Traditional Cognitive Training in Patients With Severe Acquired Brain Injury

Led by Anna Estraneo · Updated on 2025-09-29

28

Participants Needed

3

Research Sites

109 weeks

Total Duration

On this page

Sponsors

A

Anna Estraneo

Lead Sponsor

I

Istituti Clinici Scientifici Maugeri SpA

Collaborating Sponsor

AI-Summary

What this Trial Is About

Considerable evidence exists for using Virtual Reality (VR) for rehabilitation of acquired brain injury (ABI), with a particular focus on stroke. However, to date very little evidence has been collected in patients with ABI with different aetiologies (i.e., traumatic or anoxic brain injury) and level of severity (i.e., severe, sABI). The present multicentre study aims to overcome current literature issues as heterogeneity of populations and outcomes, small sample sizes and a lack of randomized controlled trials, which can affect the level of evidence and generalizability of results, to determine the effectiveness of a non immersive VR-based rehabilitation versus traditional cognitive training (TCT).

CONDITIONS

Official Title

Virtual Reality vs Traditional Cognitive Training in Patients With Severe Acquired Brain Injury

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Level of Cognitive Functioning (LCF) 4 or higher at study entry
  • Age between 18 and 75 years
  • Stable clinical diagnosis with stable LCF
  • Time since brain injury between 28 days and 6 months
  • Ability to complete the pre-test A section of the Italian Trail Making Test
  • Pathological B-A score of the Trail Making Test adjusted for age and education
  • Signed informed consent by the patient or primary caregiver
Not Eligible

You will not qualify if you...

  • Severe medical conditions that prevent participation or affect diagnosis
  • Previous neurodegenerative or acquired neurological diseases affecting cognition, such as dementia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

Sant'Angelo dei Lombardi, Avellino, Italy, 83054

Actively Recruiting

2

ICS Maugeri

Telese Terme, Benevento, Italy, 82037

Actively Recruiting

3

IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS

Milan, Italy, 20148

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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