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

NCT06474871 | Recruiting

• 1 other identifier: VR-sABI
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

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

Acquired Brain Injury

Keywords

severe acquired brain injury; rehabilitation; virtual reality; executive functions

Outcome Measures

Primary Outcomes (1)

• Trail Making Test (B-A score)

  The TMT is a neuropsychological test assessing executive functions. Higher scores indicate a better performance

  5 weeks

Secondary Outcomes (4)

• Trail Making Test (B-A score)

  1 month after treatment

• modified Barthel Index

  5 weeks - 1 month after treatment

• Disability Rating Scale

  5 weeks - 1 month after treatment

• System Usability Scale

  5 weeks - 1 month after treatment

Other Outcomes (10)

• NeuroPsychiatric Inventory

  5 weeks - 1 month after treatment

• Level of Cognitive Functioning

  5 weeks - 1 month after treatment

• Galveston Orientation and Amnesia Test

  5 weeks - 1 month after treatment

Study Arms (2)

Non-immersive VR-based training (VR)

EXPERIMENTAL

VR training focuses on enhancing executive processes but uses digital VR devices. During a VR session, the patient sits in front of the device and actively interacts with it, under the supervision of the therapist. The device contains many different exercises and for each of them the therapist can modify the virtual task scenario, increasing/decreasing its difficulty, creating a stimulating learning context in which the exercises are neither too easy nor too difficult. The exercises are divided into specific sub-domains, and include orientation, attentional processes, memory, and visual-executive functions.

Device: Khymeia®-Virtual Reality rehabilitation System (VRRS EVO SYSTEM or COMPACT VRRS ENGINE)

Traditional cognitive training (TCT)

ACTIVE COMPARATOR

the standard treatment focused on executive processes and was based on a face-to-face approach between the therapist and the patient using paper and pencil tools and other traditional materials. The training of the executive abilities is carried out by working on categorization, planning, association processes, analogical reasoning, problem solving and coping strategies to simulate problematic situations, tailored on patients' deficits, in a protected context, thanks to interaction with the cognitive therapist according to a holistic-integrated approach.

Behavioral: Traditional cognitive training (TCT)

Interventions

Khymeia®-Virtual Reality rehabilitation System (VRRS EVO SYSTEM or COMPACT VRRS ENGINE) DEVICE

fully immersive VR software created by clinicians and experts specialized in cognitive rehabilitation. Khymeia Devices are Medical Class 1 devices according to MDR. VRRS systems consist of a central process unit, complete with a capacitive touch screen LCD monitor.

Non-immersive VR-based training (VR)

Traditional cognitive training (TCT) BEHAVIORAL

face-to-face approach between the therapist and the patient using paper and pencil tools and other traditional materials. The training of the executive abilities is carried out by working on categorization, planning, association processes, analogical reasoning, problem solving and coping strategies to simulate problematic situations, tailored on patients' deficits

Traditional cognitive training (TCT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LCF ≥4 at study entry;
• Age 18-75
• Stable clinical diagnosis (i.e., stable LCF);
• Time post-injury between 28 days and 6 months;
• Ability to complete the pre-test A section of the Italian version of the Trail Making Test (TMT);
• A pathological B-A score of the TMT according to normative data adjusted for age and education;
• Signed informed consent by the patient or by the patient's primary caregiver.

You may not qualify if:

• Severe medical conditions that might hamper participation in the rehabilitation sessions, or influence diagnosis;
• Previous neurodegenerative or acquired neurological diseases that affect cognitive domains (e.g., dementia)

Sponsors & Collaborators

• Anna Estraneo: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• Ospedale Policlinico San Martino: collaborator

Study Sites (3)

Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

Sant'Angelo dei Lombardi, Avellino, 83054, Italy

RECRUITING

ICS Maugeri

Telese Terme, Benevento, 82037, Italy

RECRUITING

IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS

Milan, 20148, Italy

RECRUITING

Related Publications (1)

• Magliacano A, Fiorentino MR, Scarano G, Colella M, Fasano C, Spinola M, Monda A, Estraneo A; VR-sABI study group. Non-immersive virtual reality for cognitive rehabilitation of individuals with severe acquired brain injury (VR-sABI): study protocol for a multicentric randomized controlled trial. Trials. 2025 Oct 8;26(1):392. doi: 10.1186/s13063-025-09128-7.

  PMID: 41063192 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double blind could not be applicable since neither the participants nor the cognitive rehabilitation therapists could be blinded due to the nature of the intervention. However, clinical evaluation will be performed by an examiner blind to the patient' group of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 26, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)