Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders

Anshi Wu

Status: Not yet enrolling

Conditions: Repetitive Transcranial Magnetic Stimulation; Postoperative Cognitive Dysfunction

Treatments: Procedure: Sham Stimulation; Procedure: repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05668559

20221205

Details and patient eligibility

About

To investigate the impact of rTMS on the incidence of perioperative neurocognitive disorders in patients after after cardiac surgerysurgery. To explore the underlying mechanisms behind the efficacy.

Full description

There is a relatively high incidence of perioperative neurocognitive disorders（PND） after surgeries, and the incidence is even higher in the geriatric population undergoing cardiac surgery. Nevertheless, there remains no effective medication or intervention been approved in PND. It has been shown that brain stimulation can improve cognitive function in mild cognitively impaired patients. However, the effects on cognitive function in PND remain uninvestigated.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age 18 years or older.
• 2. ASA class I - III, patients undergoing elective cardiac surgery(coronary artery bypass grafting, aortic or mitral valve surgery).
• 3. Sign the informed consent.
• 4. Able to complete follow-up visits.

Exclusion criteria

• 1. A history of psychopathology and/or taking medication.
• 2. Previous history of neurological disease.
• 3. Severe organic diseases.
• 4. RTMS contraindications (such as a history of epileptic seizures, metal implants near the head).
• 5. Having delirium, assessed by CAM, before surgery.
• 6. Participating in other clinical studies at the time of screening.
• 7. Having a cardiopulmonary arrest and cardiopulmonary resuscitation.
• 8. Having short-term second operation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

Active rTMS Group

Experimental group

Description:

A stimulation set will be administered to each participant in the rTMS group with 15 sessions stimulation for total five days after surgery.

Treatment:

Procedure: repetitive transcranial magnetic stimulation

Sham Stimulation Group

Sham Comparator group

Description:

Patients randomly assigned to sham group will receive 15 sessions sham stimulation for total five days after surgery.

Treatment:

Procedure: Sham Stimulation