A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia (MAINSTREAM): A Study Protocol.
Maria Cotelli, Francesca Baglio, Rosa Manenti...
https://pubmed.ncbi.nlm.nih.gov/37508992Actively Recruiting
Phase Not Applicable
Age: 40Years +
All Genders
ID05730023
A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia Combining tDCS and Language Training
Led by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Updated on 2024-09-19
60
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
Sponsors
I
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Lead Sponsor
F
Fondazione Regionale per la Ricerca Biomedica
Collaborating Sponsor
AI-Summary
What this Trial Is About
Primary Progressive Aphasia (PPA) is a condition caused by various neurodegenerative disorders that mainly affect language abilities. Care for PPA patients is currently limited due to a shortage of specialists and lack of coordinated services. Researchers are evaluating a new treatment approach that combines personalized brain stimulation with language therapy to improve care in early-stage PPA. The study involves 60 patients with mild PPA who will be randomly assigned to receive either active transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex combined with individualized language training, or placebo tDCS combined with the same language training. Treatments consist of 25-minute sessions, five days a week for two weeks. Neuroimaging and biomolecular data will be collected before and after treatment to explore how tDCS may affect the brain. Participants will undergo cognitive and language testing, neurological exams, and brain scans at the start, after treatment, and three months later. Trained neuropsychologists will conduct assessments to measure changes in naming ability, language function, quality of life, dementia severity, behavior, and molecular biomarkers. This study aims to determine the effectiveness of combining tDCS with language therapy for improving symptoms in PPA over time.
CONDITIONS
Brief Title
A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931
Who Can Participate
Age: 40Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of Primary Progressive Aphasia according to current clinical criteria
- Mild Primary Progressive Aphasia based on the Progressive Aphasia Severity Scale (PASS)
- Native Italian speaker
- Age 40 years or older
You will not qualify if you...
- Presence of developmental disorders
- Any medical or psychiatric illness that could affect completion of assessments
- Any medical condition that contraindicates transcranial direct current stimulation (tDCS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 2 weeks
Participants undergo cognitive and language testing, neurologic examination, and neuroimaging (MRI or PET) to assess their condition before treatment.
Assessments at baseline (T0)
Treatment
Duration - 2 weeks
Participants receive five consecutive days a week for two weeks of 25-minute sessions of either Active or Placebo transcranial direct current stimulation (tDCS) combined with individualized language training.
10 treatment sessions over 2 weeks (in-person)
Follow-up
Duration - 3 months
Participants complete neuropsychological assessments and biomarker evaluations to measure changes after treatment and at 3 months.
Visits at post-treatment (T1) and 3-month follow-up (T2)
Trial Site Locations
Total: 4 locations
1
Maria Cotelli
Brescia, BS, Italy, 25125
Actively Recruiting
2
Tiziana Carandini
Milan, MI, Italy, 20122
Actively Recruiting
3
Francesca Baglio
Milan, MI, Italy, 20148
Actively Recruiting
4
Stefano F. Cappa
Pavia, PV, Italy, 27100
Actively Recruiting
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Research Team
M
Maria Cotelli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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