Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders

NCT ID: NCT05668559

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-04-01

Brief Summary

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.

Detailed 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.

Conditions

Postoperative Cognitive Dysfunction; Repetitive Transcranial Magnetic Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active rTMS Group

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

Group Type: EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type: PROCEDURE

The rTMS mode consists of a cluster stimulus delivered every 0.2 seconds (5 Hz), with each cluster stimulus consisting of three burst stimuli with a 50 Hz body frequency. The duration of a single stimulus was approximately 40 seconds, for a total of 600 pulses. Stimulation takes place bilaterally in the dorsolateral prefrontal cortex (DLPFC).

All enrolled patient in the rTMS group will receive 1 set simulation per day with an intersession interval (ISI) of over 30 minutes on postoperative day 1 to 5 after the surgery.

Sham Stimulation Group

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

Group Type: SHAM_COMPARATOR

Sham Stimulation

Intervention Type: PROCEDURE

Shaman stimulation uses the same protocol (600 pulses per session, 3 sessions per set, ISI≥30 min, 3 sets) with the coil set at 90 against the skull on postoperative day 1 to 5 after the surgery.

Interventions

repetitive transcranial magnetic stimulation

The rTMS mode consists of a cluster stimulus delivered every 0.2 seconds (5 Hz), with each cluster stimulus consisting of three burst stimuli with a 50 Hz body frequency. The duration of a single stimulus was approximately 40 seconds, for a total of 600 pulses. Stimulation takes place bilaterally in the dorsolateral prefrontal cortex (DLPFC).

All enrolled patient in the rTMS group will receive 1 set simulation per day with an intersession interval (ISI) of over 30 minutes on postoperative day 1 to 5 after the surgery.

Intervention Type: PROCEDURE

Sham Stimulation

Shaman stimulation uses the same protocol (600 pulses per session, 3 sessions per set, ISI≥30 min, 3 sets) with the coil set at 90 against the skull on postoperative day 1 to 5 after the surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anshi Wu

OTHER

Sponsor Role: lead

Responsible Party

Anshi Wu

Director of department of anesthesiology, Chaoyang Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anshi Wu

Role: STUDY_DIRECTOR

Beijing Chao Yang Hospital

Central Contacts

jing wang

Role: CONTACT

ruochenwangjing@163.com

+861085351330

References

Wang J, Wang X, Li S, Yang J, Yan X, Gao J, Jia X, Zuo L, Wu A, Wei C. The effect of repetitive transcranial magnetic stimulation (rTMS) on perioperative neurocognitive disorders in patients after cardiac surgery: study protocol for a randomized controlled trial. Trials. 2025 Jul 24;26(1):253. doi: 10.1186/s13063-025-08988-3.

Reference Type: DERIVED

PMID: 40707956 (View on PubMed)

Other Identifiers

20221205

Identifier Type: -

Identifier Source: org_study_id