Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- 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 Repeatable Battery Neuropsychological Status (RBANS). Besides, the changes in MOCA scores will be an additional indication of PND.
Secondary Outcome Measures
- 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).
- 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).
- 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 day before surgery 7 days after surgery 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.
- 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 day before surgery 7 days after surgery 30 days after surgery
- 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.
- 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： before anesthesia introduction during anesthesia on the 1th dayday after surgery on the 7th day after surgery on the 30th day after surgery
- Inflammatory biomarkers [Within 7 days after surgery]
Blood samples will be collected at different points of time as follows: before anesthesia introduction 1 day after surgery 3 days after surgery 7 days after surgery Levels of serum biomarkers, including but not limited to, interleukin (IL)-1β, IL-6, IL-8, tumor necrosis factor (TNF)α, Interferon (IFN)γ, Tau, vascular endothelial growth factor (VEGF)D and brain-derived neurotrophic factor (BDNF) will be examined using these specimens
- 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
- Incidence of major adverse cardiac and cerebral events [Within 30 days after surgery]
Other adverse events within 30 days after surgery were noted
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Age 18 years or older.
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- ASA class I - III, patients undergoing elective cardiac surgery(coronary artery bypass grafting, aortic or mitral valve surgery).
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- No contraindications of MRI examination.
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- Sign the informed consent.
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- Able to complete follow-up visits.
Exclusion Criteria:
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- A history of psychopathology and/or taking medication.
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- Previous history of neurological disease.
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- Severe organic diseases.
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- RTMS contraindications (such as a history of epileptic seizures, metal implants near the head).
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- Having delirium, assessed by CAM, before surgery.
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- Participating in other clinical studies at the time of screening.
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- Having uncorrectable movements during the MRI scan.
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- Having a cardiopulmonary arrest and cardiopulmonary resuscitation.
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- Having short-term second operation.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Anshi Wu
Investigators
- Study Director: Anshi Wu, Beijing Chao Yang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20221205