Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium
NCT ID: NCT04661904
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
324 participants
INTERVENTIONAL
2021-07-07
2024-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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cTBS group
Patients randomly assigned to cTBS group received 9 sessions cTBS for total three days after surgery.
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.
sham group
Patients randomly assigned to sham group received 9 sessions sham stimulation for total three days after surgery.
Sham stimulation
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.
Interventions
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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.
Sham stimulation
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.
Eligibility Criteria
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Exclusion Criteria
2. 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);
3. had mental disorders (e.g., major depressive disorder, dementia, etc.) according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);
4. had contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head);
5. participating in other clinical studies at the time of screening;
6. having postoperative complications such as pulmonary infection, pulmonary embolism and stroke.
65 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Shanghai 10th People's Hospital
OTHER
Responsible Party
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Yuan Shen, MD, PhD
Chief of Psychiatry
Principal Investigators
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Yuan Shen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai, Shanghai, China, 200072
Locations
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Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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dsyy005
Identifier Type: -
Identifier Source: org_study_id
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