Status:
NOT_YET_RECRUITING
Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Primary Progressive Aphasia(PPA)
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
This is a monocenter randomized controlled clinical trial with cross-over arm - assessor blinded. The aims is investigating the effects of the speech language therapy (SLT) alone vs SLT + non-invasive...
Detailed Description
In the landscape of neurodegenerative disorders, neuromodulation emerges as a promising avenue for therapeutic intervention, particularly for focal neurodegenerative diseases like primary progressive ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for patients
- Clinical and imaging-supported diagnosis of any variant of PPA (svPPA, lvPPA, nfvPPA) according to international diagnostic criteria (Gorno- Tempini et al., 2011)
- Age range: 40-85
- MMSE\>15
- Native Italian Speaker
- Right handedness
- Stable pharmacological treatment of at least 4 weeks and without any change during the observation period (48 weeks)
- Oral and written informed consent to study participation
- Exclusion Criteria for patients
- Any major systemic, psychiatric, neurological, and visual disturbance
- Medical conditions or substance abuse that could interfere with cognition
- Hypoacusis or severe visual deficits
- Pacemaker and/or other implanted neurostimulation devices in the head/neck district
- (Other) Contraindications to undergoing MRI examination
- Brain damage at routine MRI, including extensive cerebrovascular disorders
- Denied oral and written informed consent to study participation
- Inability to repeat multisyllabic words (4 syllables)
- Concomitant participation to other pharmacological and non pharmacological studies
- Traumatic or surgical wounds that could determine a risk of infection in the site of non-invasive stimulation
- Scalp alterations that could determine the spread of excessive current from the device.
- Known history of epilepsy (due to small risk of seizure induction from rTMS in epileptic patients
- Inclusion criteria for healthy controls:
- Sex-matched and age-matched (age range: mean age of PPA years ± 15 years)
- MMSE\>27
- Native Italian Speaker
- Right handedness
- Oral and written informed consent to study participation
- Exclusion criteria for healthy controls:
- Any major systemic, psychiatric, neurological, and visual disturbance
- Medical conditions or substance abuse that could interfere with cognition
- Hypoacusis or severe visual deficits
- Pacemaker and/or other implanted neurostimulation devices in the head/neck district
- (Other) Contraindications to undergoing MRI examination
- Brain damage at routine MRI, including extensive cerebrovascular disorders
- Denied oral and written informed consent to study participation
Exclusion
Key Trial Info
Start Date :
July 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06921265
Start Date
July 15 2025
End Date
April 1 2029
Last Update
April 10 2025
Active Locations (1)
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1
San Raffaele Neurotech Hub
Milan, Milano, Italy, 20132