Back to resultsTranscranial Magnetic Stimulation and Perioperative Neurocognitive Disorders
Primary Purpose
Postoperative Cognitive Dysfunction, Repetitive Transcranial Magnetic Stimulation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sham Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Cognitive Dysfunction
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active rTMS Group
Sham Stimulation Group
Arm Description
A stimulation set will be administered to each participant in the rTMS group with 15 sessions stimulation for total five days after surgery.
Patients randomly assigned to sham group will receive 15 sessions sham stimulation for total five days after surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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).
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
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.
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
Length of hospital stay
A hospital length of stay is the number of days the patient spends in the hospital following surgery.
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05668559
Brief Title
Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders
Official Title
The Effects of rTMS on Postoperative Cognitive Function in Patients After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anshi Wu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction, Repetitive Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active rTMS Group
Arm Type
Experimental
Arm Description
A stimulation set will be administered to each participant in the rTMS group with 15 sessions stimulation for total five days after surgery.
Arm Title
Sham Stimulation Group
Arm Type
Sham Comparator
Arm Description
Patients randomly assigned to sham group will receive 15 sessions sham stimulation for total five days after surgery.
Intervention Type
Procedure
Intervention Name(s)
repetitive transcranial magnetic stimulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of PND on the postoperative day 30
Description
Incidence of PND on the postoperative day 7 and day 30 will be defined according to the MOCA and MMSE.
Time Frame
Within 30 days after surgery
Secondary Outcome Measure Information:
Title
Postoperative delirium incidence
Description
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
Time Frame
Within 7 days after surgery
Title
Perioperative pain
Description
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).
Time Frame
Within 7 days after surgery
Title
Sleep quality
Description
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
Time Frame
Within 30 days after surgery
Title
Depressive symptom
Description
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.
Time Frame
Within 7 days after surgery
Title
Activities of daily living（ADL）
Description
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
Time Frame
Within 30 days after surgery
Title
Length of hospital stay
Description
A hospital length of stay is the number of days the patient spends in the hospital following surgery.
Time Frame
From the date of admission until discharged from hospital, up to 30 days
Title
Length of ICU stay
Description
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
Time Frame
From the date of admission until discharged from ICU, up to 30 days
Title
EEG characteristics
Description
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
Time Frame
Within 30 days after surgery
Title
Incidence of major adverse cardiac and cerebral events
Description
MACCE comprises all-cause mortality, myocardial infarction, repeat unplanned revascularization (surgical revision or percutaneous transluminal coronary angioplasty), and stroke
Time Frame
Within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jing wang
Phone
+861085351330
Email
ruochenwangjing@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anshi Wu
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Study Director
12. IPD Sharing Statement
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Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders
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