Clinical trial NCT05575583: rTMS in the Prevention and Treatment of Postoperative Executive Dysfunction
Official title: Clinical Study of Repeated Transcranial Magnetic Stimulation in the Prevention and Treatment of Postoperative Executive Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Executive Function Disorder
Functional Magnetic Resonance Imaging
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Xuzhou Medical University
First posted: 2022-10-12
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stroop color words test(SCWT)
timeFrame: Preoperative
measure: Trail making test
timeFrame: Preoperative
measure: Corsi Block test
timeFrame: Preoperative
measure: Stroop color words test(SCWT)
timeFrame: Postoperative 1 week
measure: Trail making test
timeFrame: Postoperative 1 week
measure: Corsi Block test
timeFrame: Postoperative 1 week
Secondary outcomes:
measure: Functional magnetic resonance brain network characteristics
timeFrame: Preoperative
measure: Functional magnetic resonance brain network characteristics
timeFrame: Postoperative 1 week
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Central Hospital
name: Yangzi Zhu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuzhou Central Hospital
name: Liwei Wang, Doctor
role: STUDY_DIRECTOR
affiliation: Beijing Chao Yang Hospital
name: Qi Yang, Doctor
role: STUDY_DIRECTOR
affiliation: Imperial College London, Chelsea and Westminster Hospital
name: Daqing Ma
role: STUDY_CHAIR
References: