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NCT06658769

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

Recruiting now NA Last updated 26 October 2024
What this trial tests

NA trial testing Theta Burst Stimulation in Postoperative Cognitive Dysfunction in 12 participants. Currently enrolling.

Timeline
1 April 2024
Primary endpoint
1 January 2026
31 December 2026

Quick facts

Lead sponsorUniversity of Sao Paulo General Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment12
Start date1 April 2024
Primary completion1 January 2026
Estimated completion31 December 2026
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 60 to 120, any sex, with Postoperative Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Theta Burst Stimulation

Trials testing the same drug.

Other recruiting trials for Postoperative Cognitive Dysfunction

Currently open trials in the same condition.

Other University of Sao Paulo General Hospital trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing