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Use of Transcranial Magnetic Stimulation in the Post-Operative Cognitive Dysfunction in Elderly

NCT06658769 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-26

No results posted yet for this study

Summary

Postoperative Cognitive Dysfunction (POCD) is a prevalent condition with significant clinical, social, and financial impacts on patients and healthcare services. The term POCD refers to any signs of new cognitive impairment that exceed the expected time for recovery from the acute effects of surgery and anesthesia. Mild Cognitive Impairment (MCI) is among the main risk factors and is defined as a small cognitive decline from the previous level of performance in one or more cognitive domains, without interfering with daily activities. Considering the aging population linked to an increase in the number of individuals with MCI and a growing demand for surgery, the identification of interventions that can prevent the occurrence of POCD is necessary. Non-invasive brain stimulation (NIBS) techniques such as TMS (Transcranial Magnetic Stimulation) are widely used in research and clinical practice and involve the modulation of excitability and brain activity, potentially improving the individual's cognitive performance. The aim of this study is to assess the efficacy of a Theta Burst rTMS protocol with few sessions in preventing postoperative cognitive dysfunction in elderly individuals with mild neurocognitive disorder. Methodology: This will be a randomized, blinded clinical trial with volunteers aged \> 60 years, candidates for elective surgeries, who will be randomly allocated into 2 groups: the groups will receive real or sham TBS 15 days before surgery. There will be 3 intervention sessions, with a 72-hour interval between them. Outcome measures will be cognitive psychological assessment and Stroop Test cognitive task performance before and after transcranial magnetic stimulation, after surgery and at the 3-month follow-up. There will be a non-surgical control group with cognitive impairment according to the study inclusion criteria and will receive active stimulation.

Conditions

  • Postoperative Cognitive Dysfunction

Interventions

OTHER

Theta Burst Stimulation

Transcranial Magnetic Stimulation (TMS): A non-invasive brain stimulation (NIBS) technique that involves modulating brain excitability and activity, which can increase or decrease depending on the parameters used. Theta Burst Stimulation (TBS) mimics the brain's natural firing patterns more closely and may have greater effects on cognitive performance.

OTHER

Theta Burst Stimulation Sham

Theta Burst Stimulation simulated with 90º coil orientation with lower part external to the scalp.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-01-01
Completion
2026-12-31

Countries

  • Brazil

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 NCT06658769 on ClinicalTrials.gov