Repetitive Transcranial Magnetic Stimulation and Postoperative Neurocognitive Recovery

NCT06482749 | Recruiting DMC

• 1 other identifier: 2024-232
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 3

Brief Summary

Patients with preoperative cognitive impairment are at increased risks of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). Repetitive transcranial magnetic stimulation (rTMS) has been used to improve cognitive function in patients with cognitive impairement. This trial is designed to compare the effects of rTMS versus sham intervention on postoperative neurocognitive function in patients with preoperative cognitive impairment.

Conditions

Older Patients; Cognitive Impairment; Repetitive Transcranial Magnetic Stimulation; Delayed Neurocognitive Recovery; Postoperative Neurocognitive Disorder

Keywords

Older patients; Cognitive impairment; Repetitive transcranial magnetic stimulation; Delayed neurocognitive recovery; Postoperative neurocognitive disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of delayed neurocognitive recovery

  Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher score indicating better function) before surgery and at 5 days after surgery. A MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of delayed neurocognitive recovery.

  On the 5th day after surgery

Secondary Outcomes (3)

• Incidence of delirium

  Within 5 days after surgery

• Incidence of postoperative neurocognitive disorder at 30 days after surgery

  On the 30(±3)th day after surgery

• Incidence of postoperative neurocognitive disorder at 180 days after surgery

  On the 180(±15)th day after surgery

Other Outcomes (6)

• Pain intensity within 5 days after surgery

  Up to 5 days after surgery

• Length hospital stay after surgery

  Up to 30 days after surgery

• Incidences of complications within 30 days after surgery

  Up 30 days after surgery

Study Arms (2)

Repetitive Transcranial Magnetic Stimulation Group

EXPERIMENTAL

Repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.

Device: Repetitive transcranial magnetic stimulation

Sham Stimulation Group

SHAM COMPARATOR

Sham repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped sham coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.

Device: Sham stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

Repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.

Repetitive Transcranial Magnetic Stimulation Group

Sham stimulation DEVICE

Sham repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped sham coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.

Sham Stimulation Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged ≥65 years;
• Patients with preoperative mild to moderate cognitive impairment, defined as 9\<Montreal Cognitive Assessment (MoCA)\<26;
• Scheduled for elective non-cardiac surgery under general anesthesia, with an expected surgical duration of \>2 hours;
• Expected to stay in hospital for at least 5 days after surgery.

You may not qualify if:

• Left-handed;
• Primary school education level or below;
• Comorbid diseases including mental illness, intellectual disability, auditory and visual dysfunction, language impairment, severe neurological disorders, or other diseases that impede the completion of evaluation;
• Neurosurgery;
• Presence of contraindications to rTMS treatment, including epilepsy, pregnant or lactating women, or with a metal or electric implanted device (e.g., deep brain stimulator, ventriculoperitoneal shunt, aneurysm clip, pacemaker, cochlear implant, or surgical staples on the scalp);

Sponsors & Collaborators

• Peking University First Hospital: lead
• The First Affiliated Hospital of Air Force Medicial University: collaborator
• Peking University Shenzhen Hospital: collaborator

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangzhou, 516473, China

NOT YET RECRUITING

Xijing Hospital, Air Force Medical University

Xi'an, Shannxi, 710032, China

NOT YET RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

8610 83572784; wangdongxin@hotmail.com

Hao Kong, MD

CONTACT

8610 83575138; konghao2438@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 1, 2024
• Study Start: July 28, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)