Using Transcranial Magnetic Stimulation to Prevent Cognitive Issues After Surgery in Older Adults
Use of Transcranial Magnetic Stimulation in the Prevention of Post-Operative Cognitive Dysfunction in Elderly with Mild Neurocognitive Disorder
This study tests if using Transcranial Magnetic Stimulation can help older adults avoid memory and thinking problems after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 60 Years to 120 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06658769 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Transcranial Magnetic Stimulation (TMS) to prevent Postoperative Cognitive Dysfunction (POCD) in elderly patients undergoing elective surgeries. It focuses on patients over 60 years old who may have mild cognitive impairment, assessing the effectiveness of TMS in improving cognitive outcomes post-surgery. The study employs a randomized approach, comparing active TMS treatment with a sham intervention to evaluate the potential benefits of this non-invasive brain stimulation technique.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 60 years old scheduled for elective surgeries who show signs of possible cognitive impairment.
Not a fit: Patients with major neurocognitive disorders or contraindications for TMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of cognitive decline in elderly patients after surgery.
How similar studies have performed: While the use of TMS in cognitive impairment is being explored, this specific application in postoperative settings is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
São Paulo, São Paulo
- University of Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Deise Ferreira, MSc
- Email: deise.fsilva@hc.fm.usp.br
- Phone: +55 11 98032-0345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.