Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

Not Applicable

Completed

• Conditions: Postoperative Delirium; Transcranial Magnetic Stimulation, Repetitive
• Interventions: Device: Sham stimulation; Device: Continuous theta burst stimulation (cTBS)

• Registration Number: NCT04661904
• Lead Sponsor: Shanghai 10th People's Hospital

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.

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 Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Study Start: 2021-07-30
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham group	Sham stimulation	Patients randomly assigned to sham group will receive 12 sessions sham stimulation for total four days after surgery.
cTBS group	Continuous theta burst stimulation (cTBS)	Patients randomly assigned to cTBS group will receive 12 sessions cTBS for total four days after surgery.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	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	3 days after surgery	The cognitive function related to delirium was assessed by using Delirium Symptom Interview Daily (DSI Daily).
Severity of postoperative delirium	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 Outcome Measures

Name	Time	Method
Pain level	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).
Sleep quality	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.
Ability of daily living	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.
Rate of complication and mortality	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

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, Shanghai, China