Noninvasive Brain Stimulation for pAD

NCT05468268 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-07-21

No results posted yet for this study

Summary

Episodic memory refers to the conscious recalling of a personal experience and includes information of an event and the context in which the event took place.

This function is the first to be impaired in Alzheimer's disease, a degenerative condition in which pathological changes are found initially in the medial temporal cortex and then spread in the rest of the cortex starting from post-Rolandic areas.

This study aims at examining the mechanisms that enhance memory processes, based on the information acquired by studying hypermnesic subjects. The recent discovery of subjects with an extraordinary ability to remember past events (highly above-average autobiographical memory) and the development of techniques to manipulate memory circuits in rodents provide a unique opportunity to study the mechanisms that determine the facilitation of memories.

As part of a multicenter project funded by the Ministry of Health in collaboration with La Sapienza University of Rome, the University of Perugia and the Santa Lucia Rehabilitation Center in Rome, the aspect of the project carried out at CIMeC (University of Trento) will consist in evaluating the changes induced by rTMS in patients with prodromal Alzheimer's disease, after stimulation of the regions that appear particularly active in hypermnesic subjects.

This project would offer the possibility of accessing an innovative non-invasive, and non-pharmacological treatment.

The specific objectives are:

(i) To evaluate the effectiveness of rTMS applied to hyperactive areas in hypermnesic subjects in enhancing autobiographical memories; (ii) Analyzing the neural correlates of the behavioral variations. The study will allow us to define whether it is possible to improve the recollection of autobiographical events by stimulating the circuits that are more active in hypermnesic subjects.

The results will be crucial to gain a better understanding of the mechanisms through which brain stimulation contributes to the promotion of neuroplasticity and the effects of rTMS in the prodromal stages of Alzheimer's dementia.

Conditions

  • Alzheimer's Disease - MCI

Interventions

DEVICE

20 Hz rTMS

rTMS stimulation

DEVICE

Sham rTMS

Sham stimulation

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER
  • I.R.C.C.S. Fondazione Santa Lucia

    collaborator OTHER
  • University Of Perugia

    collaborator OTHER
  • Università degli Studi di Trento

    lead OTHER

Principal Investigators

  • Costanza Papagno, MD-PhD · Università di Trento, Centro di Riabilitazione Neurocognitiva (CeRiN), Rovereto

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-04
Primary Completion
2025-12-04
Completion
2025-12-04

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05468268 on ClinicalTrials.gov