Postoperative DeliriumNCT06392919
The Impact of Repetitive Transcranial Magnetic Stimulation on the Prognosis of Elderly Surgical Patients
A study testing Repetitive Transcranial Magnetic Stimulation in people with Postoperative Delirium and Postoperative Cognitive Dysfunction, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Exploring the effects of repeated transcranial magnetic stimulation (rTMS) during the perioperative period on the incidence of postoperative delirium, postoperative cognitive dysfunction, and chronic postoperative pain in elderly patients, as well as its possible mechanisms. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Chronic Post-surgical Pain
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2024to 13 May 2025
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years;
- ASA ≤ 3;
- Elective surgery patients.
Who cannot join
- Refusal to sign the consent form;
- Mini-Mental State Examination (MMSE) score < 15;
- Preoperative neuropsychiatric diseases and history of neurological or psychiatric disorders;
- Preoperative cranial or scalp injuries;
- History of drug or alcohol abuse; Visual or auditory impairments, communication difficulties; Presence of metallic implants in the body; Preoperative history of severe cardiovascular disease or severe liver or kidney dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Perioperative Repetitive Transcranial Magnetic Stimulation on Postoperative Delirium, Postoperative Cognitive Dysfunction, and Chronic Post-surgical Pain in Elderly Surgical Patients
Exploring the effects of repeated transcranial magnetic stimulation (rTMS) during the perioperative period on the incidence of postoperative delirium, postoperative cognitive dysfunction, and chronic postoperative pain in elderly patients, as well as its possible mechanisms.
Read the detailed description
Patients are recruited one week prior to the trial commencement, during which they are informed about the experimental protocol and associated risks. After obtaining informed consent and signatures, they are enrolled as study participants.Patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham rTMS group) and the intervention group (rTMS group, with rTMS intervention applied in the PACU after surgery) in a double-blind manner (with rTMS intervention and postoperative follow-up conducted by different researchers).
Note: This trial includes three co-primary outcomes-postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and chronic postoperative pain (CPSP). To account for the different nature and timelines of these outcomes, the study was designed to include two parallel patient cohorts under a unified protocol:
- Elderly patients undergoing gastrointestinal surgery are enrolled primarily for the evaluation of POD, a short-term outcome assessed within 3 days postoperatively.
- Elderly patients undergoing thoracic surgery are enrolled to evaluate POCD (at 1 month) and CPSP (at 3 months), which are longer-term outcomes.
These two patient cohorts are studied concurrently but analyzed separately according to outcome-specific follow-up timelines and sample size estimations. A total of 122 gastrointestinal surgery patients were enrolled and analyzed for POD. The maximum estimated sample size is for the POCD and CPSP cohort (n=230). Results will be reported in phases corresponding to the completion of each outcome assessment.
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
rTMS intervention timing: rTMS is applied after the tracheal tube is removed in the PACU. Stimulation site: DLPFC (left dorsolateral prefrontal cortex); Stimulation intensity: 100% RMT; Stimulation frequency: 10Hz; Total number of stimulation pulses: 2000. Pulse characteristics: Each duration lasts 5 seconds, with a 25-second interval.
| Study group | Role | What they receive |
|---|---|---|
| Sham repetitive transcranial magnetic stimulation (rTMS group) | No intervention | After the surgical anesthesia, the patient is transferred to the Post-Anesthesia Care Unit (PACU). The Sham rTMS intervention occurs after the tracheal tube is removed in the PACU.In the sham rTMS group, the setup, including the stimulation site and parameters, is identical to that of the rTMS group. However, although the rTMS device is connected to the patient, no actual stimulation is delivered. |
| repetitive transcranial magnetic stimulation (rTMS group) | Experimental | After the surgical anesthesia, the patient is transferred to the Post-Anesthesia Care Unit (PACU). The rTMS intervention occurs after the tracheal tube is removed in the PACU. The stimulation site is the DLPFC (left dorsolateral prefrontal cortex); the stimulation intensity is 100% of the Resting Motor Threshold (RMT); the frequency is 10 Hz; and the total number of pulses is 2000. The pulse characteristics include a duration of 5 seconds per session with a 25-second interval between sessions. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium during the first 3 days after surgery
Delirium is assessed twice daily (8-10 AM and 6-8 PM) with the Confusion Assessment Method for patients without endotracheal intubation during the first 3 days after surgery.
Measured: The first 3 days after surgery
Incidence of Postoperative Cognitive Dysfunction
Cognitive function assessed with MoCA (Montreal Cognitive Assessment) test on the 30th day after surgery
Measured: 1 month after surgery
Incidence of chronic postsurgical pain (CPSP) at 3 months after surgery
CPSP is defined as pain persisting for at least three months after surgery that was not present before surgery or that had different characteristics, and other possible causes of pain were excluded (e.g., cancer recurrence, infection). Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain, both at rest and with movement.
Measured: At 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start3 May 2024
- Primary completion13 May 2025
- Study completion13 May 2025
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 DeliriumStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaochao Zhong, Affiliated Hospital of Nantong University
- Investigators
- Chao-Chao Zhong, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392919
- Sponsor's protocol ID
- 2024-K005-01
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou WW, Yang Z, Zhou C, Qiao Q, Zhang YH, Hu J, Gao YN, Chen LE, Yang WW, Qin YB, Zhong CC. Early repetitive transcranial magnetic stimulation for preventing chronic postoperative pain in older adults: a randomized clinical sub-study. BMC Med. 2026 Apr 6;24(1):316. doi: 10.1186/s12916-026-04845-5.
PubMed 41943114
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Repetitive Transcranial Magnetic Stimulation on Postoperative Delirium, Postoperative Cognitive Dysfunction, and Chronic Post-surgical Pain in Elderly Surgical Patients
- ClinicalTrials.gov ID
- NCT06392919
- Acronym / sponsor ID
- 2024-K005-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 1 May 2024 (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.
Exploring the effects of repeated transcranial magnetic stimulation (rTMS) during the perioperative period on the incidence of postoperative delirium, postoperative cognitive dysfunction, and chronic postoperative pain in elderly patients, as well as its possible mechanisms.
Detailed description
Patients are recruited one week prior to the trial commencement, during which they are informed about the experimental protocol and associated risks. After obtaining informed consent and signatures, they are enrolled as study participants.Patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham rTMS group) and the intervention group (rTMS group, with rTMS intervention applied in the PACU after surgery) in a double-blind manner (with rTMS intervention and postoperative follow-up conducted by different researchers).
Note: This trial includes three co-primary outcomes-postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and chronic postoperative pain (CPSP). To account for the different nature and timelines of these outcomes, the study was designed to include two parallel patient cohorts under a unified protocol:
- Elderly patients undergoing gastrointestinal surgery are enrolled primarily for the evaluation of POD, a short-term outcome assessed within 3 days postoperatively.
- Elderly patients undergoing thoracic surgery are enrolled to evaluate POCD (at 1 month) and CPSP (at 3 months), which are longer-term outcomes.
These two patient cohorts are studied concurrently but analyzed separately according to outcome-specific follow-up timelines and sample size estimations. A total of 122 gastrointestinal surgery patients were enrolled and analyzed for POD. The maximum estimated sample size is for the POCD and CPSP cohort (n=230). Results will be reported in phases corresponding to the completion of each outcome assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham repetitive transcranial magnetic stimulation (rTMS group) | No intervention | –After the surgical anesthesia, the patient is transferred to the Post-Anesthesia Care Unit (PACU). The Sham rTMS intervention occurs after the tracheal tube is removed in the PACU.In the sham rTMS group, the setup, including the stimulation site and parameters, is identical to that of the rTMS group. However, although the rTMS device is connected to the patient, no actual stimulation is delivered. |
| repetitive transcranial magnetic stimulation (rTMS group) | Experimental | Device: Repetitive Transcranial Magnetic StimulationAfter the surgical anesthesia, the patient is transferred to the Post-Anesthesia Care Unit (PACU). The rTMS intervention occurs after the tracheal tube is removed in the PACU. The stimulation site is the DLPFC (left dorsolateral prefrontal cortex); the stimulation intensity is 100% of the Resting Motor Threshold (RMT); the frequency is 10 Hz; and the total number of pulses is 2000. The pulse characteristics include a duration of 5 seconds per session with a 25-second interval between sessions. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 60 years;
- ASA ≤ 3;
- Elective surgery patients.
Key exclusion criteria (5 listed)
- Refusal to sign the consent form;
- Mini-Mental State Examination (MMSE) score < 15;
- Preoperative neuropsychiatric diseases and history of neurological or psychiatric disorders;
- Preoperative cranial or scalp injuries;
- History of drug or alcohol abuse; Visual or auditory impairments, communication difficulties; Presence of metallic implants in the body; Preoperative history of severe cardiovascular disease or severe liver or kidney dysfunction.
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 StimulationrTMS intervention timing: rTMS is applied after the tracheal tube is removed in the PACU. Stimulation site: DLPFC (left dorsolateral prefrontal cortex); Stimulation intensity: 100% RMT; Stimulation frequency: 10Hz; Total number of stimulation pulses: 2000. Pulse characteristics: Each duration lasts 5 seconds, with a 25-second interval. | Device | repetitive transcranial magnetic stimulation (rTMS group) |
Primary outcome
Incidence of delirium during the first 3 days after surgery
Time frame: The first 3 days after surgery
Delirium is assessed twice daily (8-10 AM and 6-8 PM) with the Confusion Assessment Method for patients without endotracheal intubation during the first 3 days after surgery.
Incidence of Postoperative Cognitive Dysfunction
Time frame: 1 month after surgery
Cognitive function assessed with MoCA (Montreal Cognitive Assessment) test on the 30th day after surgery
Incidence of chronic postsurgical pain (CPSP) at 3 months after surgery
Time frame: At 3 months after surgery
CPSP is defined as pain persisting for at least three months after surgery that was not present before surgery or that had different characteristics, and other possible causes of pain were excluded (e.g., cancer recurrence, infection). Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain, both at rest and with movement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Derived from this study: PubMed 41943114Zhou WW, Yang Z, Zhou C, Qiao Q, Zhang YH, Hu J, Gao YN, Chen LE, Yang WW, Qin YB, Zhong CC. Early repetitive transcranial magnetic stimulation for preventing chronic postoperative pain in older adults: a randomized clinical sub-study. BMC Med. 2026 Apr 6;24(1):316. doi: 10.1186/s12916-026-04845-5.
- Individual participant dataSharing planned: No
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Chao-Chao Zhong principal investigator
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Postoperative Delirium and Postoperative Cognitive Dysfunction, run by Affiliated Hospital of Nantong University at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium during the first 3 days after surgery (time frame: The first 3 days after surgery). The study lists 3 primary outcomes in all. 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 NCT06392919, 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 29 Sep 2026.