Actively Recruiting

Phase Not Applicable
Age: 60Years - 120Years
All Genders
NCT06658769

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

Led by University of Sao Paulo General Hospital · Updated on 2024-10-26

12

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 60Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 60 years old
  • Scheduled for elective moderate or large surgeries with general or spinal anesthesia
  • Possible or probable cognitive impairment based on pre-operative 10-point cognitive screening
  • Non-surgical control group must meet age and cognitive impairment criteria
Not Eligible

You will not qualify if you...

  • Metal implants in the head or contraindications to Transcranial Magnetic Stimulation
  • History of seizures, epilepsy, brain trauma, brain surgery, or intracranial hypertension
  • Medical diagnosis of major neurocognitive disorder (any dementia)
  • Indication for skull surgery
  • Severe hearing or vision loss or inability to understand Portuguese
  • Current medication changes affecting brain electrical activity (antidepressants, antipsychotics)
  • Difficulty attending treatment or follow-up due to socioeconomic or clinical reasons
  • Surgery scheduled earlier than the study timeline allows

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Sao Paulo

São Paulo, São Paulo, Brazil, 01246903

Actively Recruiting

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Research Team

D

Deise Ferreira, MSc

CONTACT

C

Clarice Tanaka, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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