rTMS in the Prevention and Treatment of Postoperative Executive Dysfunction

October 10, 2022 updated by: Xuzhou Central Hospital

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Sham Comparator: 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.
Device: pseudo repetitive transcranial magnetic stimulation
Participant in control group receive pseudo repetitive transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Central Hospital

Collaborators

The Affiliated Hospital of Xuzhou Medical University

Investigators

  • Study Director: Qi Yang, Doctor, Affiliated Beijing Chaoyang Hospital of Capital Medical University
  • Study Chair: Daqing Ma, Imperial College London, Chelsea and Westminster Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 30, 2022

Primary Completion (Anticipated)

July 30, 2025

Study Completion (Anticipated)

September 30, 2025

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • XuzhouCH20221001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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