Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders

The Effects of rTMS on Postoperative Cognitive Function in Patients After Cardiac Surgery

To investigate the impact of rTMS on the incidence of perioperative neurocognitive disorders in patients after after cardiac surgerysurgery. To explore the underlying mechanisms behind the efficacy.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Cognitive Dysfunction; Repetitive Transcranial Magnetic Stimulation
• Intervention / Treatment: Procedure: repetitive transcranial magnetic stimulation; Procedure: Sham Stimulation

Detailed Description

There is a relatively high incidence of perioperative neurocognitive disorders（PND） after surgeries, and the incidence is even higher in the geriatric population undergoing cardiac surgery. Nevertheless, there remains no effective medication or intervention been approved in PND. It has been shown that brain stimulation can improve cognitive function in mild cognitively impaired patients. However, the effects on cognitive function in PND remain uninvestigated.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jing wang; Phone Number: +861085351330; Email: ruochenwangjing@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Age 18 years or older.
• 2. ASA class I - III, patients undergoing elective cardiac surgery(coronary artery bypass grafting, aortic or mitral valve surgery).
• 3. Sign the informed consent.
• 4. Able to complete follow-up visits.

Exclusion Criteria:

• 1. A history of psychopathology and/or taking medication.
• 2. Previous history of neurological disease.
• 3. Severe organic diseases.
• 4. RTMS contraindications (such as a history of epileptic seizures, metal implants near the head).
• 5. Having delirium, assessed by CAM, before surgery.
• 6. Participating in other clinical studies at the time of screening.
• 7. Having a cardiopulmonary arrest and cardiopulmonary resuscitation.
• 8. Having short-term second operation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active rTMS Group; A stimulation set will be administered to each participant in the rTMS group with 15 sessions stimulation for total five days after surgery.	Procedure: repetitive transcranial magnetic stimulation; The rTMS mode consists of a cluster stimulus delivered every 0.2 seconds (5 Hz), with each cluster stimulus consisting of three burst stimuli with a 50 Hz body frequency. The duration of a single stimulus was approximately 40 seconds, for a total of 600 pulses. Stimulation takes place bilaterally in the dorsolateral prefrontal cortex (DLPFC). All enrolled patient in the rTMS group will receive 1 set simulation per day with an intersession interval (ISI) of over 30 minutes on postoperative day 1 to 5 after the surgery.
Sham Comparator: Sham Stimulation Group; Patients randomly assigned to sham group will receive 15 sessions sham stimulation for total five days after surgery.	Procedure: Sham Stimulation; Shaman stimulation uses the same protocol (600 pulses per session, 3 sessions per set, ISI≥30 min, 3 sets) with the coil set at 90 against the skull on postoperative day 1 to 5 after the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of PND on the postoperative day 30	Incidence of PND on the postoperative day 7 and day 30 will be defined according to the MOCA and MMSE.	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse cardiac and cerebral events	MACCE comprises all-cause mortality, myocardial infarction, repeat unplanned revascularization (surgical revision or percutaneous transluminal coronary angioplasty), and stroke	Within 30 days after surgery
Perioperative pain	This will be assessed by using Visual Analogue Scale (VAS). The patients scored according to the severity of their pain from no pain (0) to most painful (10).	Within 7 days after surgery
Sleep quality	We will use the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. PSQI uses a 19-item questionnaire to assess sleep quality over one month30. An increased score indicates poor quality sleep. PSQI will be recorded at different points of time as follows： 1 day before surgery; 7 days after surgery; 30 days after surgery	Within 30 days after surgery
Depressive symptom	Depressive disorder and depression symptom severity will be measured using the 9-item patient health questionnaire (PHQ-9). It is self-administered and carries a score ranging from 0 to 27, with a score range of 0 to 3. Five, ten, fifteen, and twenty are the thresholds for mild, moderate, and moderately severe depression.	Within 7 days after surgery
Activities of daily living（ADL）	As part of the pre-surgery and post-surgery evaluations, the Chinese version of the ADL scale will be used, including a Physical Self-Maintenance Scale and an Instrumental ADL scale. ADL consists of 14 items, and the total score ranges between 14 and 56 points, with higher scores indicating a lower level of functioning. ADL will be evaluated at different points of time as follows： 1 day before surgery; 7 days after surgery; 30 days after surgery	Within 30 days after surgery
Length of hospital stay	A hospital length of stay is the number of days the patient spends in the hospital following surgery.	From the date of admission until discharged from hospital, up to 30 days
Length of ICU stay	Similarly, the ICU length of stay was defined as the number of days the patient spent in the ICU before transferring to a general inpatient cardiac surgery ward	From the date of admission until discharged from ICU, up to 30 days
EEG characteristics	Electroencephalography will be recorded at different points of time as follows and EEG characteristics including power in alpha, beta, theta, delta, gamma, spectrum will be extracted using MATLAB. In addition, functional brain connectivity and brain network will be assessed at different points of time as follows： before anesthesia introduction; during anesthesia; on the 1th dayday after surgery; on the 7th day after surgery; on the 30th day after surgery	Within 30 days after surgery
Postoperative delirium incidence	Incidence of postoperative delirium on postoperative day 1 to 7 will be defined by the Confusion Assessment Method for The Intensive Care Unit (CAM-ICU) or CAM	Within 7 days after surgery

Collaborators and Investigators

• Sponsor: Anshi Wu
• Investigators: Study Director: Anshi Wu, Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: 20221205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No