NCT06658769 · RECRUITING
Use of Transcranial Magnetic Stimulation in the Post-Operative Cognitive Dysfunction in Elderly
This trial is testing whether a brain stimulation technique called Theta Burst TMS — delivered in three sessions before surgery — can help prevent memory and thinking problems that sometimes appear after major operations in older adults. Participants already have mild cognitive impairment and are 60 or older. It is a Phase NA randomized trial, meaning it is evaluating whether the approach works, but it is not yet proven or approved for this purpose.
You may qualify if
- Patients over 60 years old
- Patients scheduled for elective surgeries of moderate or large scale and candidates for general or spinal anesthesia;
- 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.
You're excluded if
- 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);
- Medical diagnosis of Major Neurocognitive Disorder (any form of dementia, regardless of the stage);
- Indication for skull surgery;
- Conditions that interfere with cognitive testing (presence of severe hearing and vision loss, inability to understand Portuguese);
- Ongoing medication adjustments that affect cortical electrical activity (antidepressants, antipsychotics);
- Difficulty attending treatment during the stipulated evaluation and follow-up period, whether due to socioeconomic or clinical reasons;
- Anticipation of surgical scheduling;
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-10-26