rTMS in the Prevention and Treatment of Postoperative Executive Dysfunction

Xuzhou Central Hospital (Xuzhou Fourth People's Hospital)

Status: Enrolling

Conditions: Executive Function Disorder; Functional Magnetic Resonance Imaging

Treatments: Device: repetitive transcranial magnetic stimulation; Device: pseudo repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05575583

XuzhouCH20221001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

400 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Device: repetitive transcranial magnetic stimulation

Control group

Sham Comparator group

Description:

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.

Treatment:

Device: pseudo repetitive transcranial magnetic stimulation