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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05575583
Enrollment
400
Registered
2022-10-12
Start date
2022-11-30
Completion date
2025-09-30
Last updated
2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Executive Function Disorder, Functional Magnetic Resonance Imaging

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.

Interventions

DEVICErepetitive 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.

DEVICEpseudo repetitive transcranial magnetic stimulation

Participant in control group receive pseudo repetitive transcranial magnetic stimulation

Sponsors

The Affiliated Hospital of Xuzhou Medical University
CollaboratorOTHER
Xuzhou Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stroop color words test(SCWT)PreoperativeThe Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function
Trail making testPreoperativeTrail Making test (TMT) was used to evaluate the set switching in executive function
Corsi Block testPreoperativeThe visuospatial working memory of executive function was assessed by the Corsi Block test

Secondary

MeasureTime frameDescription
Functional magnetic resonance brain network characteristicsPreoperativeThe 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.

Countries

China

Contacts

Primary ContactLiwei Wang, Doctor
doctorlww@sina.com+86 18952170255
Backup ContactYangzi Zhu, Doctor
zhuyz@188.com+86 18168779150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026