Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

Not Applicable

Completed

• Conditions: Postoperative Delirium
• Interventions: Device: Continuous theta burst stimulation (cTBS)

• Registration Number: NCT05239897
• Lead Sponsor: RenJi Hospital

Brief Summary

To determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients.

Detailed Description

Postoperative delirium(POD), a syndrome characterized by an acute change in attention, awareness and cognition, is one of the most common postoperative complications among elderly patients. Impaired neuronal network connectivity is likely one of the several neurobiological processes that contribute to POD pathogenesis. Recently, continuous theta burst stimulation (cTBS) was demonstrated to improve cognitive function in patients with mild cognitive impairment.Recent research suggests that cTBS has positive effect on improving the connectivity and reorganization of the brain network. Therefore, we plan to conduct an exploratory study in participants undergoing elective surgeries to determine whether cTBS can cure POD in this senior patient population.

Study Timeline

• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Study Start: 2022-02-07
• Study First Posted: 2022-02-15
• Primary Completion: 2023-02-28
• Study Completion: 2023-03-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Aged between 60 to 80 years;
• Having delirium after elective surgery;
• Being able to complete cognitive assessment and confusion assessment methods (CAM);
• Willing to participate before surgery and being competent to provide informed consent.

Exclusion Criteria

• Having brain tumor, stroke, or mental disorders (e.g., depression or dementia);
• Having contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head or heart);
• Participating in other clinical studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
postoperative delirium	Continuous theta burst stimulation (cTBS)	We will use Confusion Assessment Method (CAM) to determine the incidence of postoperative delirium in participants twice per day. We will use the Memorial Delirium Assessment Scale(MDAS)and Mini-mental state examination(MMSE) to examine postoperative delirium severity.

Primary Outcome Measures

Name	Time	Method
Cure rate of POD after a single cTBS treatment	7 days after surgery	No POD was evaluated by CAM at 1 hour after a single cTBS treatment on the day of the first occurrence of POD and at any time point thereafter.

Secondary Outcome Measures

Name	Time	Method
Cure rate of POD after multiple cTBS treatments	7 days after surgery	No POD was evaluated by CAM at 1 hour after two or three cTBS treatments and at any time point thereafter.
Severity of postoperative delirium changed after each cTBS treatment	7 days after surgery	Severity of postoperative delirium on postoperative day 1 to 7 will be defined according to MDAS.

Trial Locations

Locations (1)

Renji hospital, School of medicine, Shanghai Jiaotong University; 🇨🇳 Pudong, Shanghai, China