New treatment approach for Primary Progressive Aphasia using brain stimulation and language training
A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931
This study is testing a new treatment that combines brain stimulation with language training to see if it can help people with Primary Progressive Aphasia communicate better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 4 sites (Brescia, BS and 3 other locations) |
| Trial ID | NCT05730023 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop a multimodal approach for diagnosing and treating Primary Progressive Aphasia (PPA) by combining transcranial direct current stimulation (tDCS) with individualized language training. A total of 60 patients diagnosed with PPA will be recruited from multiple institutions in Italy, where they will undergo cognitive and language assessments, neurologic examinations, and neuroimaging. Participants will be divided into two groups, one receiving active tDCS and the other receiving a placebo, with evaluations conducted at baseline, post-treatment, and at a three-month follow-up to assess the effectiveness of the intervention. The study seeks to improve the understanding of neurodegeneration and provide personalized treatment options for patients with PPA.
Who should consider this trial
Good fit: Ideal candidates for this study are Italian native speakers diagnosed with mild Primary Progressive Aphasia.
Not a fit: Patients with developmental disorders or other medical conditions that could interfere with assessments or contraindicate tDCS will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance language function and overall quality of life for patients with Primary Progressive Aphasia.
How similar studies have performed: While there is limited research specifically on PPA, similar approaches using tDCS in other neurodegenerative conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis PPA according to the current clinical criteria (Gorno-Tempini et al., 2011); * Mild PPA defined using the Progressive Aphasia Severity Scale (PASS); * Italian native speakers. Exclusion Criteria: * Presence of developmental disorders; * Presence of any medical or psychiatric illness that could interfere in completing assessments; * Presence of any medical condition that represents a contraindication to tDCS.
Where this trial is running
Brescia, BS and 3 other locations
- Maria Cotelli — Brescia, Bs, Italy (Recruiting)
- Tiziana Carandini — Milan, Mi, Italy (Recruiting)
- Francesca Baglio — Milan, Mi, Italy (Recruiting)
- Stefano F. Cappa — Pavia, Pv, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Cotelli — IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli
- Study coordinator: Maria Cotelli
- Email: mcotelli@fatebenefratelli.eu
- Phone: 00390303501457
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.