Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

NCT04661904 | Completed DMC

• 1 other identifier: dsyy005
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium; Transcranial Magnetic Stimulation, Repetitive

Keywords

postoperative delirium; continuous theta burst stimulation

Outcome Measures

Primary Outcomes (3)

• Incidence of postoperative delirium

  Incidence of postoperative delirium on postoperative day 1, 2 and 3 was defined according to the confusion assessment methods (CAM).

  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).

  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).

  3 days after surgery

Secondary Outcomes (4)

• Pain level

  3 days after surgery

• Sleep quality

  3 days after surgery

• Ability of daily living

  up to 7 days after anesthesia/surgery

• Rate of complication and mortality

  up to 7 days after anesthesia/surgery

Study Arms (2)

cTBS group

EXPERIMENTAL

Patients randomly assigned to cTBS group received 9 sessions cTBS for total three days after surgery.

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.

Device: Sham stimulation

Interventions

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.

cTBS group

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.

sham group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Participants were included if they: 1. were 65 years old or older; 2. had orthopedic surgery under general anesthesia; 3. had normal cognitive function at enrolment \[for illiterate, Mini-Mental State Examination (MMSE) ≥ 17; for individuals with 1-6 years of education, MMSE ≥ 20; for individuals with 7 or more years of education, MMSE ≥ 24\]; 4. were able to complete cognitive assessments and the Confusion Assessment Method (CAM); 5. Chinese Mandarin as their native language; 6. were willing to participate and being competent to provide informed consent. Patients were excluded if they: 1. had delirium assessed by CAM before surgery; 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

• 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.

  PMID: 34400453 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yuan Shen, MD, PhD

  Shanghai, Shanghai, China, 200072

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychiatry

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 10, 2020
• Study Start: July 7, 2021
• Primary Completion: December 2, 2024
• Study Completion: December 13, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)