Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06920784

Prismatic Adaptation in Cognitive Rehabilitation

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-03-25

50

Participants Needed

5

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Prismatic Adaptation in Cognitive Rehabilitation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Diagnosis of traumatic brain injury (TBI)
  • Rancho Level of Cognitive Functioning for TBI patients greater than 4
  • Admission to rehabilitation within 90 days from injury onset
Not Eligible

You will not qualify if you...

  • Presence of unilateral spatial neglect
  • Aphasia
  • Severe vigilance deficits
  • Severe verbal comprehension deficits
  • Motor deficits affecting both hands
  • Previous neurological stroke
  • History of neurological disease
  • History of psychiatric disease
  • Use of alcohol or drugs
  • Severe visual deficits
  • Premorbid dementia

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Istituti Clinici Scientifici Maugeri IRCCS

Bari, Italy, 70124

Actively Recruiting

2

Istituti Clinici Scientifici Maugeri IRCCS

Bari, Italy, 70124

Actively Recruiting

3

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Italy, 27100

Actively Recruiting

4

Istituti Clinici Scientifici Maugeri IRCCS

Sciacca, Italy, 92019

Actively Recruiting

5

Istituti Clinici Scientifici Maugeri IRCCS

Telese Terme, Italy, 82037

Actively Recruiting

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Research Team

S

Simona Spaccavento, Psychologist

CONTACT

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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Prismatic Adaptation in Cognitive Rehabilitation | DecenTrialz