Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

Study Overview
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Brief Summary
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To determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients.

Detailed Description
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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.

Official Title
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Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation: an Exploratory Study

Conditions
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Postoperative Delirium, Continuous Theta Burst Stimulation

Intervention / Treatment
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* Device: Continuous theta burst stimulation (cTBS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: postoperative delirium<br>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. | Device: Continuous theta burst stimulation (cTBS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 7 days after surgery |