Assessment and treatment for communication issues in neurological and psychiatric conditions
"Assessment and Treatment of Communicative Pragmatic Abilities in Neurological and Psychiatric Disorders: Feasibility and Clinical Efficacy (PATHS)"
This study is trying to find better ways to help people with communication problems caused by brain injuries or mental health issues, by testing a new treatment and a quick test for their language skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Camillo, Venezia, Italy Academic / other |
| Locations | 4 sites (Milano, MI and 3 other locations) |
| Trial ID | NCT05809401 on ClinicalTrials.gov |
What this trial studies
This project aims to develop a comprehensive approach for assessing and treating pragmatic language disorders in patients with neurological and psychiatric conditions such as stroke, traumatic brain injury, and schizophrenia. It includes three work packages: creating a short test for pragmatic abilities, testing a novel treatment for pragmatic disorders through a randomized control trial, and investigating the neural correlates of pragmatic abilities using high-density EEG recordings. The study will involve both healthy participants and patients, focusing on improving communication and quality of life for affected individuals.
Who should consider this trial
Good fit: Ideal candidates include individuals with right hemisphere damage, traumatic brain injury, or a diagnosis of schizophrenia.
Not a fit: Patients with significant comorbidities that may affect the results of the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this study could significantly enhance communication abilities and overall quality of life for patients with pragmatic language disorders.
How similar studies have performed: While pragmatic language disorders are often overlooked, this approach is novel and aims to fill a significant gap in assessment and treatment, suggesting limited prior studies have explored this specific methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Healthy participants * no neurological disorder * written informed consent Right Hemisphere Damage (RHD) * unilateral stroke * first stroke * no comorbidities with psychiatric disorders * written informed consent TBI * traumatic brain injury * written informed consent Schizophrenia: * Diagnosis of Schizophrenia * written informed consent Exclusion Criteria: * Important comorbidities that may affect results
Where this trial is running
Milano, MI and 3 other locations
- IRCCS San Raffaele — Milano, Mi, Italy (Recruiting)
- IRCCS Eugenio Medea — Pieve Di Soligo, Tv, Italy (Recruiting)
- Istituto Universitario di Studi Superiori Pavia — Pavia, Italy (Recruiting)
- IRCCS San Camillo Hospital — Venice, Italy (Recruiting)
Study contacts
- Principal investigator: Arcara — IRCCS San Camillo Hospital
- Study coordinator: Giorgio Arcara
- Email: giorgio.arcara@hsancamillo.it
- Phone: 0412207594
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.