Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

RenJi Hospital20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postoperative Delirium

Interventions

Continuous theta burst stimulation (cTBS)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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Renji hospital, School of medicine, Shanghai Jiaotong University

Pudong, Shanghai Municipality, China

Outcomes

Primary Outcomes

Cure rate of POD after a single cTBS treatment

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.

Time frame: 7 days after surgery

Secondary Outcomes

Cure rate of POD after multiple cTBS treatments

No POD was evaluated by CAM at 1 hour after two or three cTBS treatments and at any time point thereafter.

Time frame: 7 days after surgery

Severity of postoperative delirium changed after each cTBS treatment

Severity of postoperative delirium on postoperative day 1 to 7 will be defined according to MDAS.

Time frame: 7 days after surgery

Data from ClinicalTrials.gov

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