Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05239897
• Other study ID #: cTBStPOD
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2022
• Source: RenJi Hospital
• Contact: Diansan Su
• Phone: +86 18616514088
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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