Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

NCT ID: NCT05239897

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2023-03-15

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.

Conditions

Postoperative Delirium

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

postoperative delirium

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.

Group Type: EXPERIMENTAL

Continuous theta burst stimulation (cTBS)

Intervention Type: DEVICE

Patients assessed for postoperative delirium will be treated by consist 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.

Interventions

Continuous theta burst stimulation (cTBS)

Patients assessed for postoperative delirium will be treated by consist 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renji hospital, School of medicine, Shanghai Jiaotong University

Pudong, Shanghai Municipality, China

Countries

China

Other Identifiers

cTBStPOD

Identifier Type: -

Identifier Source: org_study_id