rTMS in the Prevention and Treatment of Postoperative Executive Dysfunction

Study Overview
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Brief Summary
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Repetitive transcranial magnetic stimulation (rTMS) is a new neuroelectrophysiological technique developed in recent years. rTMS can affect local and distant cortical function, promote regional reconstruction of cortical function, and has clear curative effect on a variety of neuropsychiatric diseases. Previous study found that rTMS can improve postoperative cognitive function, and there may be a dual biological mechanism. Brain network abnormalities may be the direct cause of postoperative cognitive dysfunction, and neuroinflammation is one of the key molecular mechanisms behind postoperative cognitive dysfunction . rTMS may play a role in the regulation of brain network and inflammatory molecules, and thus play a role in the prevention and treatment of postoperative cognitive dysfunction (POCD).

Detailed Description
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This study intends to use neuroimaging methods to observe the correlation between neuroinflammation and brain network abnormalities in patients with POCD, and verify the repair effect of rTMS intervention on the pathological changes, so as to provide a theoretical basis for further optimizing the establishment of rTMS localization therapy model for POCD.

Official Title
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Clinical Study of Repeated Transcranial Magnetic Stimulation in the Prevention and Treatment of Postoperative Executive Dysfunction

Conditions
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Executive Function Disorder, Functional Magnetic Resonance Imaging

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation
* Device: pseudo repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart valve replacement. 45 to 75 years old. Exclusion Criteria: definite cerebral infarction. failure and decompensation of vital organs physical metal implants. severe neuropsychiatric disorders. less than 9 years of education. alcohol abuse. drug dependence.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Subjects underwent repetitive transcranial magnetic stimulation for five consecutive days from day 2 to day 6 after surgery. The stimulation target area was the posterior cingulate gyrus, and the neuronavigation system was used to accurately locate the stimulation target in this project. Continuous theta short rapid pulse mode (cTBS) was used. CTBS mode consisted of a slave stimulus delivered every 0.2 seconds (5Hz), and each slave stimulus consisted of three bursts of 50Hz. A single stimulus lasts about 40 seconds and totals 600 pulses. Stimulation sessions are from 8 to 10 a.m. daily. | Device: repetitive transcranial magnetic stimulation<br>* The neural navigation system was used to accurately locate the stimulus target.Continuous theta short rapid pulse mode was used. CTBS mode consisted of a slave stimulus delivered every 0.2 seconds (5Hz), and each slave stimulus consisted of three bursts of 50Hz. A single stimulus lasts about 40 seconds and totals 600 pulses.<br>|
| Sham Comparator: Control group<br>Subjects underwent repetitive transcranial magnetic stimulation for five consecutive days from day 2 to day 6 after surgery，but the machine does not turn on. | Device: pseudo repetitive transcranial magnetic stimulation<br>* Participant in control group receive pseudo repetitive transcranial magnetic stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroop color words test(SCWT) | The Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function | Preoperative | 
| Trail making test | Trail Making test (TMT) was used to evaluate the set switching in executive function | Preoperative | 
| Corsi Block test | The visuospatial working memory of executive function was assessed by the Corsi Block test | Preoperative | 
| Stroop color words test(SCWT) | The Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function | Postoperative 1 week | 
| Trail making test | Trail Making test (TMT) was used to evaluate the set switching in executive function | Postoperative 1 week | 
| Corsi Block test | The visuospatial working memory of executive function was assessed by the Corsi Block test | Postoperative 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional magnetic resonance brain network characteristics | The changes of brain network between intervention group and control group before and after operation were compared. Resting-state fMRI and task-state fMRI were evaluated. | Preoperative | 
| Functional magnetic resonance brain network characteristics | The changes of brain network between intervention group and control group before and after operation were compared. Resting-state fMRI and task-state fMRI were evaluated. | Postoperative 1 week |