Postoperative DeliriumNCT04661904
Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium
A study testing Continuous theta burst stimulation (cTBS) in people with Postoperative Delirium and Transcranial Magnetic Stimulation, Repetitive, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To investigate the impact of cTBS on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. To explore whether short-term cTBS can reduce the risk of postoperative delirium as a preventive strategy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Transcranial Magnetic Stimulation, Repetitive
- What is being tested?
- Continuous theta burst stimulation (cTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2021to 13 Dec 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Participants were included if they:
- were 65 years old or older;
- had orthopedic surgery under general anesthesia;
- had normal cognitive function at enrolment [for illiterate, Mini-Mental State Examination (MMSE) ≥ 17; for individuals with 1-6 years of education, MMSE ≥ 20; for individuals with 7 or more years of education, MMSE ≥ 24];
- were able to complete cognitive assessments and the Confusion Assessment Method (CAM);
- Chinese Mandarin as their native language;
- were willing to participate and being competent to provide informed consent.
Patients were excluded if they:
- had delirium assessed by CAM before surgery;
- had neurological diseases (e.g., stroke, Parkinson's disease, etc.) according to International Statistical Classification of Diseases and Related Health Problems 11th Revision (ICD-11);
- had mental disorders (e.g., major depressive disorder, dementia, etc.) according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);
- had contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head);
- participating in other clinical studies at the time of screening;
- having postoperative complications such as pulmonary infection, pulmonary embolism and stroke.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: Effect of Continuous Theta Burst Stimulation (cTBS) on Postoperative Delirium
To investigate the impact of cTBS on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. To explore whether short-term cTBS can reduce the risk of postoperative delirium as a preventive strategy.
Read the detailed description
Postoperative delirium is the most common postoperative complications among elderly. Nevertheless, there remains no effective medication or intervention been approved in postoperative delirium. Recent research suggests that continuous theta burst stimulation (cTBS) has shown positive effect on improving global cognitive function in multiple mental disorders. However, the effects on cognitive function in postoperative delirium remain uninvestigated.
- Being tested
- Continuous theta burst stimulation (cTBS), Sham stimulation
- Keywords
- postoperative delirium, continuous theta burst stimulation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous theta burst stimulation (cTBS)Device
Our active treatment consisted of 600 pulses per session, delivered over the right dorsolateral prefrontal cortex at 80% of resting motor threshold (RMT). Every session cTBS consists of 50 Hz triplets of pulses delivered at 5 Hz for 40 seconds for a total of 600 pulses. Every set simulation includes 3 sessions. All enrolled patient in the cTBS group received 1 set simulation per day with an intersession interval (ISI) of over 30 minutes during the hospitalization after the surgery. The first set of stimulation was given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation were given at 8 am, 8:30 am and 9:00 am on postoperative day 1and 2, respectively.
Sham stimulationDevice
The sham stimulation group received a sham cTBS (600 pulses per session, 3 sessions per day, ISI ≥ 30mins, 3 days) with the coil set at 90 against the skull. The first set of stimulation was given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation were given at 8 am, 8:30 am and 9:00 am on postoperative day 1 and 2, respectively.
| Study group | Role | What they receive |
|---|---|---|
| cTBS group | Experimental | Patients randomly assigned to cTBS group received 9 sessions cTBS for total three days after surgery. Receives: Device: Continuous theta burst stimulation (cTBS) |
| sham group | Sham comparator | Patients randomly assigned to sham group received 9 sessions sham stimulation for total three days after surgery. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Incidence of postoperative delirium on postoperative day 1, 2 and 3 was defined according to the confusion assessment methods (CAM).
Measured: 3 days after surgery
Cognitive function related to delirium
The cognitive function related to delirium was assessed by using Delirium Symptom Interview Daily (DSI Daily).
Measured: 3 days after surgery
Severity of postoperative delirium
Severity of postoperative delirium on postoperative day 1, 2 and 3 was defined according to he Confusion Assessment Method based delirium severity evaluation tool (CAM-S).The sum score of CAM-S ranges from 0 (no) to 19 (most severe).
Measured: 3 days after surgery
Secondary outcomes (4)
Pain level
This was 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: 3 days after surgery
Sleep quality
leep Quality was assessed by the Pittsburgh Sleep Quality Index (PSQI) at baseline (T0), and DSI Daily after surgery.The global PSQI score ranges from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 3 days after surgery
Ability of daily living
This was assessed by using Chinese version of Activity of Daily Living (ADL) Scale.The total score of ADLs ranges from 14 to 56 points and higher ADLs scores indicate lower activities of daily living.
Measured: up to 7 days after anesthesia/surgery
Rate of complication and mortality
Rate of complication and mortality during the stay in hospital or up to 7 days after anesthesia/surgery, depending which one is longer
Measured: up to 7 days after anesthesia/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start7 Jul 2021
- Primary completion2 Dec 2024
- Study completion13 Dec 2024
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Yuan Shen, MD, PhD, Shanghai 10th People's Hospital
- Investigators
- Yuan Shen, MD, PhD, Principal investigator, Shanghai, Shanghai, China, 200072
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661904
- Sponsor's protocol ID
- dsyy005
- Status last verified
- Apr 2025
- First submitted
- 26 Nov 2020
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei X, Wang M, Ma X, Tang T, Shi J, Zhao D, Yuan T, Xie Z, Shen Y. Treatment of postoperative delirium with continuous theta burst stimulation: study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 16;11(8):e048093. doi: 10.1136/bmjopen-2020-048093.
PubMed 34400453
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Theta Burst Stimulation (cTBS) on Postoperative Delirium
- ClinicalTrials.gov ID
- NCT04661904
- Acronym / sponsor ID
- dsyy005
- Keywords
- postoperative delirium, continuous theta burst stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 10 Dec 2020 (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 cTBS on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. To explore whether short-term cTBS can reduce the risk of postoperative delirium as a preventive strategy.
Detailed description
Postoperative delirium is the most common postoperative complications among elderly. Nevertheless, there remains no effective medication or intervention been approved in postoperative delirium. Recent research suggests that continuous theta burst stimulation (cTBS) has shown positive effect on improving global cognitive function in multiple mental disorders. However, the effects on cognitive function in postoperative delirium remain uninvestigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cTBS group | Experimental | Device: Continuous theta burst stimulation (cTBS)Patients randomly assigned to cTBS group received 9 sessions cTBS for total three days after surgery. |
| sham group | Sham comparator | Device: Sham stimulationPatients randomly assigned to sham group received 9 sessions sham stimulation for total three days after surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Continuous theta burst stimulation (cTBS)Our active treatment consisted of 600 pulses per session, delivered over the right dorsolateral prefrontal cortex at 80% of resting motor threshold (RMT). Every session cTBS consists of 50 Hz triplets of pulses delivered at 5 Hz for 40 seconds for a total of 600 pulses. Every set simulation includes 3 sessions. All enrolled patient in the cTBS group received 1 set simulation per day with an intersession interval (ISI) of over 30 minutes during the hospitalization after the surgery. The first set of stimulation was given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation were given at 8 am, 8:30 am and 9:00 am on postoperative day 1and 2, respectively. | Device | cTBS group |
| Sham stimulationThe sham stimulation group received a sham cTBS (600 pulses per session, 3 sessions per day, ISI ≥ 30mins, 3 days) with the coil set at 90 against the skull. The first set of stimulation was given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation were given at 8 am, 8:30 am and 9:00 am on postoperative day 1 and 2, respectively. | Device | sham group |
Primary outcome
Incidence of postoperative delirium
Time frame: 3 days after surgery
Incidence of postoperative delirium on postoperative day 1, 2 and 3 was defined according to the confusion assessment methods (CAM).
Cognitive function related to delirium
Time frame: 3 days after surgery
The cognitive function related to delirium was assessed by using Delirium Symptom Interview Daily (DSI Daily).
Severity of postoperative delirium
Time frame: 3 days after surgery
Severity of postoperative delirium on postoperative day 1, 2 and 3 was defined according to he Confusion Assessment Method based delirium severity evaluation tool (CAM-S).The sum score of CAM-S ranges from 0 (no) to 19 (most severe).
4 secondary outcomes
Pain level
Time frame: 3 days after surgery
Sleep quality
Time frame: 3 days after surgery
Ability of daily living
Time frame: up to 7 days after anesthesia/surgery
Rate of complication and mortality
Time frame: up to 7 days after anesthesia/surgery
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 15 Aug 2025.
- Derived from this study: PubMed 34400453Wei X, Wang M, Ma X, Tang T, Shi J, Zhao D, Yuan T, Xie Z, Shen Y. Treatment of postoperative delirium with continuous theta burst stimulation: study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 16;11(8):e048093. doi: 10.1136/bmjopen-2020-048093.
- Individual participant dataSharing planned: No
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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.
Yuan Shen, MD, PhD principal investigator
Shanghai, Shanghai, China, 200072
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous theta burst stimulation (cTBS) in people with Postoperative Delirium and Transcranial Magnetic Stimulation, Repetitive, run by Shanghai 10th People's Hospital 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?
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 15 Aug 2025. 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. 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?
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 postoperative delirium (time frame: 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 NCT04661904, 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 15 Aug 2025.