Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: Device: Continuous theta burst stimulation (cTBS)

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Pudong, Shanghai, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium
• Other Study ID Numbers: cTBStPOD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No