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TPSAlz - Transcranial Pulse Stimulation in Alzheimer's Disease
Sponsor: IRCCS San Raffaele Roma
Summary
The goal of this study is to evaluate the effects of transcranial pulse stimulation (TPS) in modulating cognitive functions as well as structural and functional connectivity in individuals with mild cognitive impairment and early Alzheimer's disease. The main outcome measure is to confirm whether TPS may be considered as an effective treatment to improve memory in a large cohort of participants and investigating its long-term effects. Then, secondary measurements are to evaluate if TPS may induce neuronal connectivity changes and may confirm previous results exploring whether this innovative technique may induce, in a long and short-term period, possible effects on cortical atrophy and structural connectivity. An additional outcomes is to evaluate if TPS may have a positive impact on global cognitive functioning and behavioral profile.
Official title: Effects of Transcranial Pulse Stimulation on Functional and Structural Brain Connectivity in Mild Cognitive Impairment and in the Early Stages of Alzheimer's Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2024-05-30
Completion Date
2026-09-30
Last Updated
2026-10-20
Healthy Volunteers
No
Interventions
Transcranial pulse stimulation (TPS)
All patients will receive either real TPS or sham treatment once a day for five days/weekly for four weeks. Each daily TPS session takes approximately 30 minutes. TPS produces single ultrashort pulses with a frequency spectrum ranging from 1 to 8 Hz. Ultrasound pulses will be applied using a NEUROLITH TPS generator. Technical parameters will be set as follows: 0.2-0.25 mJ mm2 energy flux density, pulse repetition frequency of 3.5 Hz, 6000 pulses per session. Before the stimulation, individual 3D T1 isometric voxel MRI scans will be performed to allow TPS neuronavigation. Therefore, regions of interest (ROIs) from each participant will be defined by a trained neurologist to target brain areas, as frontal lobe, parietal lobe, precuneus and left/right hippocampus, typically involved in AD pathology.
Locations (1)
IRCCS San Raffaele
Roma, Italy, Italy