Using prismatic adaptation and serious games for cognitive rehabilitation in traumatic brain injury
Prismatic Adaptation for Cognitive Rehabiliation in Traumatic Brain Injury Patients
This study is testing if using special glasses and fun games can help people with traumatic brain injury improve their thinking skills better than regular rehab methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 5 sites (Bari and 4 other locations) |
| Trial ID | NCT06920784 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of prismatic adaptation combined with serious games on cognitive and behavioral deficits in patients with traumatic brain injury (TBI). It compares this novel rehabilitation protocol to traditional rehabilitation methods without prismatic adaptation. The study also aims to assess functional cognitive outcomes and changes in resting-state EEG patterns during treatment. By exploring these innovative interventions, the research seeks to enhance cognitive functions and improve rehabilitation strategies for TBI patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have suffered a traumatic brain injury and have a Rancho Level of Cognitive Functioning greater than 4.
Not a fit: Patients with severe cognitive deficits, such as unilateral spatial neglect or severe verbal comprehension deficits, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive rehabilitation outcomes for patients with traumatic brain injury.
How similar studies have performed: While the combination of prismatic adaptation and serious games is a novel approach, previous studies have shown promise in using prismatic adaptation for cognitive rehabilitation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bari and 4 other locations
- Istituti Clinici Scientifici Maugeri IRCCS — Bari, Italy (Recruiting)
- Istituti Clinici Scientifici Maugeri IRCCS — Bari, Italy (Recruiting)
- Istituti Clinici Scientifici Maugeri IRCCS — Pavia, Italy (Recruiting)
- Istituti Clinici Scientifici Maugeri IRCCS — Sciacca, Italy (Recruiting)
- Istituti Clinici Scientifici Maugeri IRCCS — Telese Terme, Italy (Recruiting)
Study contacts
- Principal investigator: Simona Spaccavento — Istituti Clinici Scientifici Maugeri IRCCS
- Study coordinator: Simona Spaccavento, Psychologist
- Email: simona.spaccavento@icsmaugeri.it
- Phone: +393332783524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.