rTMS in the Prevention and Treatment of Postoperative Executive Dysfunction
Clinical Study of Repeated Transcranial Magnetic Stimulation in the Prevention and Treatment of Postoperative Executive Dysfunction
1 other identifier
interventional
400
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedStudy Start
First participant enrolled
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedMarch 8, 2023
September 1, 2022
2.7 years
September 29, 2022
March 7, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (2)
Functional magnetic resonance brain network characteristics
Preoperative
Functional magnetic resonance brain network characteristics
Postoperative 1 week
Study Arms (2)
Intervention group
EXPERIMENTALSubjects 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.
Control group
SHAM COMPARATORSubjects underwent repetitive transcranial magnetic stimulation for five consecutive days from day 2 to day 6 after surgery，but the machine does not turn on.
Interventions
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.
Participant in control group receive pseudo repetitive transcranial magnetic stimulation
Eligibility Criteria
You may qualify if:
- Heart valve replacement.
- to 75 years old.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yangzi Zhu, Doctor
Xuzhou Central Hospital
- STUDY DIRECTOR
Liwei Wang, Doctor
Xuzhou Central Hospital
- STUDY DIRECTOR
Qi Yang, Doctor
Beijing Chao Yang Hospital
- STUDY CHAIR
Daqing Ma
Imperial College London, Chelsea and Westminster Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2022
First Posted
October 12, 2022
Study Start
November 30, 2022
Primary Completion
July 30, 2025
Study Completion
September 30, 2025
Last Updated
March 8, 2023
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share