rTMS in the Prevention and Treatment of Postoperative Executive Dysfunction

NCT ID: NCT05575583

Last Updated: 2023-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2025-09-30

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.

Conditions

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Executive Function Disorder Functional Magnetic Resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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.

Control group

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.

Group Type SHAM_COMPARATOR

pseudo repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Participant in control group receive pseudo repetitive transcranial magnetic stimulation

Interventions

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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.

Intervention Type DEVICE

pseudo repetitive transcranial magnetic stimulation

Participant in control group receive pseudo repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

Xuzhou Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yangzi Zhu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Xuzhou Central Hospital

Liwei Wang, Doctor

Role: STUDY_DIRECTOR

Xuzhou Central Hospital

Qi Yang, Doctor

Role: STUDY_DIRECTOR

Beijing Chao Yang Hospital

Daqing Ma

Role: STUDY_CHAIR

Imperial College London, Chelsea and Westminster Hospital

Locations

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Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liwei Wang, Doctor

Role: CONTACT

+86 18952170255

Yangzi Zhu, Doctor

Role: CONTACT

+86 18168779150

Facility Contacts

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Yangzi Zhu, Doctor

Role: primary

+86 18168779150

Other Identifiers

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XuzhouCH20221001

Identifier Type: -

Identifier Source: org_study_id

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