NCT06920784 Prismatic Adaptation in Cognitive Rehabilitation
| NCT ID | NCT06920784 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-11-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
Inclusion Criteria: * Age \>18 years * Traumatic brain injury (TBI) * Rancho Level of Cognitive Functioning (LCF) for TBI patients \> 4 * Admission within 90 days from the onset Exclusion Criteria: * 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 & Investigator
Simona Spaccavento
PRINCIPAL INVESTIGATOR
Istituti Clinici Scientifici Maugeri IRCCS
Frequently Asked Questions
Who can join the NCT06920784 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06920784 currently recruiting?
Yes, NCT06920784 is actively recruiting participants. Contact the research team at simona.spaccavento@icsmaugeri.it for enrollment information.
Where is the NCT06920784 trial being conducted?
This trial is being conducted at Bari, Italy, Bari, Italy, Pavia, Italy, Sciacca, Italy and 1 additional location.
Who is sponsoring the NCT06920784 clinical trial?
NCT06920784 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The principal investigator is Simona Spaccavento at Istituti Clinici Scientifici Maugeri IRCCS. The trial plans to enroll 50 participants.