Use of Transcranial Magnetic Stimulation in the Post-Operative Cognitive Dysfunction in Elderly
Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Oct 23, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called Transcranial Magnetic Stimulation (TMS) to see if it can help prevent Postoperative Cognitive Dysfunction (POCD) in older adults. POCD is a condition where patients experience significant memory or thinking problems that last longer than expected after surgery. The trial focuses on elderly individuals, particularly those over 60 years old, who have mild cognitive impairment and are scheduled for certain types of elective surgeries. Participants will be divided into two groups: one will receive the TMS treatment, while the other will receive a placebo treatment that does not have any active effect.
To be eligible for the trial, participants must be 60 years or older and scheduled for moderate or major surgeries under general or spinal anesthesia. They should also show some signs of cognitive impairment based on a simple screening test. During the study, participants will undergo three sessions of TMS treatment in the weeks leading up to their surgery and will be assessed on their cognitive skills before and after the treatment, as well as three months after the surgery. This trial is important because it seeks to identify a potential way to improve the cognitive recovery of elderly patients after surgery, which can have a significant impact on their quality of life.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patients over 60 years old
- • 2. Patients scheduled for elective surgeries of moderate or large scale and candidates for general or spinal anesthesia;
- • 3. Patients who demonstrate possible or probable cognitive impairment based on pre-operative screening using the 10-CS (10-point cognitive screening) tool; - For Non-surgical Control Intervention Group, only the first and third criteria will be applied.
- Exclusion Criteria:
- • 1. Contraindications for the use of Transcranial Magnetic Stimulation (metal implants in the head, history of seizures or epilepsy, brain trauma or surgery, intracranial hypertension, and complications from exposure to magnetic fields);
- • 2. Medical diagnosis of Major Neurocognitive Disorder (any form of dementia, regardless of the stage);
- • 3. Indication for skull surgery;
- • 4. Conditions that interfere with cognitive testing (presence of severe hearing and vision loss, inability to understand Portuguese);
- • 5. Ongoing medication adjustments that affect cortical electrical activity (antidepressants, antipsychotics);
- • 6. Difficulty attending treatment during the stipulated evaluation and follow-up period, whether due to socioeconomic or clinical reasons;
- • 7. Anticipation of surgical scheduling;
About University Of Sao Paulo General Hospital
The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sao Paulo, , Brazil
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported