rTMS in the Prevention and Treatment of Postoperative Executive Dysfunction

Functional Magnetic Resonance Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575583
• Other study ID #: XuzhouCH20221001
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2022
• Source: Xuzhou Central Hospital
• Contact: Liwei Wang, Doctor
• Phone: +86 18952170255
• Email: doctorlww[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Executive Function Disorder
• Functional Magnetic Resonance Imaging

Intervention

Device:
• repetitive transcranial magnetic stimulation
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.
• pseudo repetitive transcranial magnetic stimulation
Participant in control group receive pseudo repetitive transcranial magnetic stimulation

Locations

Country	Name	City	State
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Xuzhou Central Hospital	The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

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