Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

8mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach

1 country

5 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.1 years study duration

Study Progress70%

Nov 2024Dec 2026

Study Start

First participant enrolled

November 7, 2024

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed

2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

February 4, 2025

Last Update Submit

March 24, 2026

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injuryprismatic adaptationcognitive rehabilitationserious games

Outcome Measures

Primary Outcomes (1)

Neuropsychological primary outcome measure
\- Montreal Cognitive Assessment (MoCA) (0-30). High score means a better outcome.
From the enrollment to the end of treatment at 2 weeks.

Secondary Outcomes (12)

Neurophysiological secondary outcome
From the enrollment to the end of treatment at 2 weeks.
Neuropsychiatric outcome
From the enrollment to the end of treatment at 2 weeks.
Neuropsychological outcome measure
From the enrollment to the end of treatment at 2 weeks.
Neuropsychological outcome measure
From the enrollment to the end of treatment at 2 weeks.
Neuropsychological outcome measure
From the enrollment to the end of treatment at 2 weeks.
+7 more secondary outcomes

Other Outcomes (2)

Functional cognitive secondary outcome
From the enrollment to the end of treatment at 2 weeks.
Functional secondary outcome
From the enrollment to the end of treatment at 2 weeks.

Study Arms (2)

Prismatic adaptation group

EXPERIMENTAL

Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session. This training will be administered using a class I medical device SaMD (Software as a Medical Device) associated to prisms.

Device: PRISMATIC ADAPTATIONDevice: Serious games

Control group

SHAM COMPARATOR

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

Device: Serious games

Interventions

PRISMATIC ADAPTATIONDEVICE

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.

Prismatic adaptation group

Serious gamesDEVICE

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

Control groupPrismatic adaptation group

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.