What this means
Researchers plan to test whether short magnetic brain stimulation before surgery can help prevent thinking problems afterward. This trial has not reported any results yet, so it does not show whether it works.
Plain-English summary written by an AI model from the registry listing.
- Status
- Recruiting
- Who can join
- Ages 60–120
- Where
- 1 site
The science
- Registered title
- Use of Transcranial Magnetic Stimulation in the Post-Operative Cognitive Dysfunction in Elderly
- Trial ID
- NCT06658769 ↗
- Phase
- Not applicable
- Study type
- interventional
- Conditions
- Postoperative Cognitive Dysfunction
- What is tested
- Theta Burst Stimulation, Theta Burst Stimulation Sham
- Sponsor
- University of Sao Paulo General Hospital
- Ages
- 60 Years to 120 Years
- Dates
- First posted Oct 26, 2024 · updated Oct 26, 2024
Registry summary
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.
Sites (1)
- University of Sao Paulo, São Paulo, São Paulo, Brazil
