Prismatic Adaptation in Cognitive Rehabilitation

Recruiting now · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT06920784

Run by

Istituti Clinici Scientifici Maugeri SpA

People needed

50

Starts

2024-11-07

Expected to finish

2026-12-31

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Traumatic brain injury (TBI)
• Rancho Level of Cognitive Functioning (LCF) for TBI patients > 4
• Admission within 90 days from the onset

You may not qualify if…

• Unilateral Spatial Neglect
• Aphasia
• Severe vigilance deficits
• Severe verbal comprehension deficits
• Motor deficits of both hands
• Previous neurological stroke
• Previous neurological disease
• Previous psychiatric disease
• Use of alcohol or drugs
• Severe visual deficits
• Premorbid dementia

Where it is running

• Istituti Clinici Scientifici Maugeri IRCCS — Bari, Italy (enrolling)
• Istituti Clinici Scientifici Maugeri IRCCS — Bari, Italy (enrolling)
• Istituti Clinici Scientifici Maugeri IRCCS — Pavia, Italy (enrolling)
• Istituti Clinici Scientifici Maugeri IRCCS — Sciacca, Italy (enrolling)
• Istituti Clinici Scientifici Maugeri IRCCS — Telese Terme, Italy (enrolling)

Full record on ClinicalTrials.gov

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