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Network-based rTMS in Alzheimer's Disease

NCT04263194 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-13

No results posted yet for this study

Summary

Severe alterations of brain networks connectivity have been described in Alzheimer's disease (AD). Repetitive Transcranial Magnetic Stimulation (rTMS) has gained evidence as an effective tool to modulate brain networks connectivity, leading to a recovery or reorganization of both local and remote brain regions functionally connected to the stimulated area. The investogators propose an innovative tailored network-based rTMS treatment to ameliorate cognitive symptoms in mild AD, through the boosting of connectivity within brain networks affected by AD pathophysiology. The combination of the proposed intervention with an integrated multi-modal imaging approach will allow to evaluate the neural mechanisms underlying the clinical response to the treatment and to define quantitative markers of clinical impact on AD. If successful, the present proposal would immediately impact on patient's quality of life, with important implications for the time and costs of delivery of rehabilitative services.

Conditions

  • Alzheimer Disease, Late Onset
  • Alzheimer Disease
  • Cognitive Deterioration

Interventions

DEVICE

rTMS

25 min of high frequency (20 Hz) repetitive TMS applied at 100% of resting motor threshold (rMT).

DEVICE

Sham rTMS

Placebo intervention will consist in the same procedure but using a sham rTMS coil.

Sponsors & Collaborators

  • I.R.C.C.S. Fondazione Santa Lucia

    collaborator OTHER

  • Ministero della Salute, Italy

    collaborator OTHER

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    lead OTHER

Principal Investigators

  • Debora Brignani · IRCCS Centro San Giovanni di Dio Fatebenefratelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2023-09-21
Completion
2024-03-21

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 NCT04263194 on ClinicalTrials.gov