Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders

Not Applicable

Not yet recruiting

• Conditions: Postoperative Cognitive Dysfunction; Repetitive Transcranial Magnetic Stimulation
• Interventions: Procedure: Sham Stimulation; Procedure: repetitive transcranial magnetic stimulation

• Registration Number: NCT05668559
• Lead Sponsor: Anshi Wu

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-05
• Study Start: 2023-10-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stimulation Group	Sham Stimulation	Patients randomly assigned to sham group will receive 15 sessions sham stimulation for total five days after surgery.
Active rTMS Group	repetitive transcranial magnetic stimulation	A stimulation set will be administered to each participant in the rTMS group with 15 sessions stimulation for total five days after surgery.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Activities of daily living（ADL）	Within 30 days after surgery	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. 1 day before surgery; 2. 7 days after surgery; 3. 30 days after surgery
Perioperative pain	Within 7 days after surgery	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).
Postoperative delirium incidence	Within 7 days after surgery	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
Sleep quality	Within 30 days after surgery	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. 1 day before surgery; 2. 7 days after surgery; 3. 30 days after surgery
Depressive symptom	Within 7 days after surgery	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.
Length of hospital stay	From the date of admission until discharged from hospital, up to 30 days	A hospital length of stay is the number of days the patient spends in the hospital following surgery.
Incidence of major adverse cardiac and cerebral events	Within 30 days after surgery	MACCE comprises all-cause mortality, myocardial infarction, repeat unplanned revascularization (surgical revision or percutaneous transluminal coronary angioplasty), and stroke
Length of ICU stay	From the date of admission until discharged from ICU, up to 30 days	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
EEG characteristics	Within 30 days after surgery	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： 1. before anesthesia introduction; 2. during anesthesia; 3. on the 1th dayday after surgery; 4. on the 7th day after surgery; 5. on the 30th day after surgery