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Completed

NCT Number: NCT04661904

Continuous Theta Burst Stimulation (cTBS) and 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 stimulation

Device

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. Pain level

    Time frame: 3 days after surgery

    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).

  2. Sleep quality

    Time frame: 3 days after surgery

    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.

  3. Ability of daily living

    Time frame: up to 7 days after anesthesia/surgery

    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.

  4. Rate of complication and mortality

    Time frame: up to 7 days after anesthesia/surgery

    Rate of complication and mortality during the stay in hospital or up to 7 days after anesthesia/surgery, depending which one is longer

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

Effect of Continuous Theta Burst Stimulation (cTBS) on Postoperative Delirium

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2020
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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