NCT05668559

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

December 6, 2022

Last Update Submit

August 30, 2023

Conditions

Postoperative Cognitive DysfunctionRepetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • The incidence of PND on the postoperative day 30

    Incidence of PND on the postoperative day 7 and day 30 will be defined according to the MOCA and MMSE.

    Within 30 days after surgery

Secondary Outcomes (9)

  • Postoperative delirium incidence

    Within 7 days after surgery

  • Perioperative pain

    Within 7 days after surgery

  • Sleep quality

    Within 30 days after surgery

  • Depressive symptom

    Within 7 days after surgery

  • Activities of daily living（ADL）

    Within 30 days after surgery

  • +4 more secondary outcomes

Study Arms (2)

Active rTMS Group

EXPERIMENTAL

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

Procedure: repetitive transcranial magnetic stimulation

Sham Stimulation Group

SHAM COMPARATOR

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

Procedure: Sham Stimulation

Interventions

repetitive transcranial magnetic stimulationPROCEDURE

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.

Active rTMS Group
Sham StimulationPROCEDURE

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.

Sham Stimulation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 40707956DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Anshi Wu

    Beijing Chao Yang Hospital

    STUDY DIRECTOR

Central Study Contacts

jing wang

CONTACT

+861085351330ruochenwangjing@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of department of anesthesiology, Chaoyang Hospital

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 30, 2022

Study Start

October 1, 2023

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

September 5, 2023

Record last verified: 2023-08