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Prismatic Adaptation in Cognitive Rehabilitation

NCT06920784 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-25

No results posted yet for this study

Summary

The study aims to evaluate the effects of prismatic adaptation and then of a novel rehabilitation protocol that combines PA and Serious Games on cognitive and behavioural deficits in patients with traumatic brain injury , compared to a rehabilitation training without prismatic adaptation.

Moreover, this study aims to assess the impact of this rehabilitation protocol on functional cognitive outcomes.

Hypothesis Hypothesis 1 (H1): It is postulated that the utilization of Prismatic Adaptation Treatment (PAT) has a positive impact on the enhancement of cognitive outcome among patients suffering from TBI

Hypothesis 2 (H2): It is hypothesized that there will be discernible alterations in resting-state Electroencephalography (EEG) patterns between the initial assessment point (T0) and the subsequent measurement during the course of treatment (T1) in individuals diagnosed with TBI

Assessment times of outcome measures will be conducted before the experimental treatment (T0) and after the 10 rehabilitation sessions (T1).

Patients will be randomized into two groups:

1. Experimental group: Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session.
2. Control group: patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.

Both groups will receive also the standard cognitive rehabilitation for the detected deficits, using paper and pen materials.

Each rehabiliation session will last aproximately 1 hour for 5 days a week for 2 weeks.

Conditions

Interventions

DEVICE

PRISMATIC ADAPTATION

The experimental treatment includes a session of prismatic adaptation, in which patients, wearing priasmatic lenses, performs pointing exercises using an 11'' tablet. The visual target is represented by a black squares randomly presented in one of three spatial positions of the tablet's screen (in the centre of the screen or at 21° to the right or to the left space). Taking into account the type of lesion resulting from traumatic brain injury, the prismatic deviation induced by the lenses will be changed alternately from right to left. Then patients will wear rightward prism lenses for 5 days and leftward prism lenses for other 5 days. The prismatic deviation will be randomized. Following these prismatic adaptation, lasting 10 minutes, cognitive training with serious games will be performed, for the remaining 30 minutes.

DEVICE

Serious games

patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Principal Investigators

  • Simona Spaccavento · Istituti Clinici Scientifici Maugeri IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-07
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06920784 on ClinicalTrials.gov