Postoperative Cognitive DysfunctionNCT05668559
Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders
A study testing repetitive transcranial magnetic stimulation in people with Postoperative Cognitive Dysfunction and Repetitive Transcranial Magnetic Stimulation, run by Anshi Wu.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of rTMS on Postoperative Cognitive Function in Patients After Cardiac Surgery
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.
Read the 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.
- Being tested
- repetitive transcranial magnetic stimulation, Sham Stimulation
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationProcedure or surgery
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 StimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after surgery
Secondary outcomes (9)
Postoperative delirium incidence
Incidence of postoperative delirium on postoperative day 1 to 7 will be defined by the Confusion Assessment Method for The Intensive Care Unit (CAM-ICU) or CAM
Measured: Within 7 days after surgery
Perioperative pain
This will be assessed by using Visual Analogue Scale (VAS). The patients scored according to the severity of their pain from no pain (0) to most painful (10).
Measured: Within 7 days after surgery
Sleep quality
We will use the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. PSQI uses a 19-item questionnaire to assess sleep quality over one month30. An increased score indicates poor quality sleep. PSQI will be recorded at different points of time as follows：
- 1 day before surgery
- 7 days after surgery
- 30 days after surgery
Measured: Within 30 days after surgery
Depressive symptom
Depressive disorder and depression symptom severity will be measured using the 9-item patient health questionnaire (PHQ-9). It is self-administered and carries a score ranging from 0 to 27, with a score range of 0 to 3. Five, ten, fifteen, and twenty are the thresholds for mild, moderate, and moderately severe depression.
Measured: Within 7 days after surgery
Activities of daily living（ADL）
As part of the pre-surgery and post-surgery evaluations, the Chinese version of the ADL scale will be used, including a Physical Self-Maintenance Scale and an Instrumental ADL scale. ADL consists of 14 items, and the total score ranges between 14 and 56 points, with higher scores indicating a lower level of functioning. ADL will be evaluated at different points of time as follows：
- 1 day before surgery
- 7 days after surgery
- 30 days after surgery
Measured: Within 30 days after surgery
Length of hospital stay
A hospital length of stay is the number of days the patient spends in the hospital following surgery.
Measured: From the date of admission until discharged from hospital, up to 30 days
Length of ICU stay
Similarly, the ICU length of stay was defined as the number of days the patient spent in the ICU before transferring to a general inpatient cardiac surgery ward
Measured: From the date of admission until discharged from ICU, up to 30 days
EEG characteristics
Electroencephalography will be recorded at different points of time as follows and EEG characteristics including power in alpha, beta, theta, delta, gamma, spectrum will be extracted using MATLAB. In addition, functional brain connectivity and brain network will be assessed at different points of time as follows：
- before anesthesia introduction
- during anesthesia
- on the 1th dayday after surgery
- on the 7th day after surgery
- on the 30th day after surgery
Measured: Within 30 days after surgery
Incidence of major adverse cardiac and cerebral events
MACCE comprises all-cause mortality, myocardial infarction, repeat unplanned revascularization (surgical revision or percutaneous transluminal coronary angioplasty), and stroke
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Oct 2023 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anshi Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anshi Wu, Beijing Chao Yang Hospital
- Investigators
- Anshi Wu, Study director, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668559
- Sponsor's protocol ID
- 20221205
- Status last verified
- Aug 2023
- First submitted
- 6 Dec 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40707956
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of rTMS on Postoperative Cognitive Function in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05668559
- Acronym / sponsor ID
- 20221205
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Anshi WuUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS Group | Experimental | Procedure: repetitive transcranial magnetic stimulationA stimulation set will be administered to each participant in the rTMS group with 15 sessions stimulation for total five days after surgery. |
| Sham Stimulation Group | Sham comparator | Procedure: Sham StimulationPatients randomly assigned to sham group will receive 15 sessions sham stimulation for total five days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulationThe 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. | Procedure or surgery | Active rTMS Group |
| Sham StimulationShaman 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. | Procedure or surgery | Sham Stimulation Group |
Primary outcome
The incidence of PND on the postoperative day 30
Time frame: Within 30 days after surgery
Incidence of PND on the postoperative day 7 and day 30 will be defined according to the MOCA and MMSE.
9 secondary outcomes
Postoperative delirium incidence
Time frame: Within 7 days after surgery
Perioperative pain
Time frame: Within 7 days after surgery
Sleep quality
Time frame: Within 30 days after surgery
Depressive symptom
Time frame: Within 7 days after surgery
Activities of daily living（ADL）
Time frame: Within 30 days after surgery
Length of hospital stay
Time frame: From the date of admission until discharged from hospital, up to 30 days
Length of ICU stay
Time frame: From the date of admission until discharged from ICU, up to 30 days
EEG characteristics
Time frame: Within 30 days after surgery
Incidence of major adverse cardiac and cerebral events
Time frame: Within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 40707956Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anshi Wu study director
Beijing Chao Yang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Postoperative Cognitive Dysfunction and Repetitive Transcranial Magnetic Stimulation, run by Anshi Wu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jing wang (+861085351330, ruochenwangjing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PND on the postoperative day 30 (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.