Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

NCT05239897 | Completed DMC

• 1 other identifier: cTBStPOD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cure rate of POD after multiple cTBS treatments

  7 days after surgery

• Severity of postoperative delirium changed after each cTBS treatment

  7 days after surgery

Study Arms (1)

postoperative delirium

EXPERIMENTAL

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)

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.

postoperative delirium

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji hospital, School of medicine, Shanghai Jiaotong University

Pudong, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: February 7, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 15, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

CN (1)