Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05668559
• Other study ID #: 20221205
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: August 2023
• Source: Beijing Chao Yang Hospital
• Contact: jing wang
• Phone: +861085351330
• Email: ruochenwangjing[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: April 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Repetitive Transcranial Magnetic Stimulation

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anshi Wu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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