Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07883148
NA

TPSAlz - Transcranial Pulse Stimulation in Alzheimer's Disease

Sponsor: IRCCS San Raffaele Roma

View on ClinicalTrials.gov

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

DEVICE

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