Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

Postoperative Delirium Clinical Trial

Official title:

Effect of Continuous Theta Burst Stimulation (cTBS) on Postoperative Delirium

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04661904
• Other study ID #: dsyy005
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2021
• Source: Shanghai 10th People's Hospital
• Contact: Yuan Shen, MD, PhD
• Phone: 2166303649
• Email: kmshy[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the impact of cTBS on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. To explore whether short-term cTBS can reduce the risk of postoperative delirium as a preventive strategy.

Description:

Postoperative delirium is the most common postoperative complications among elderly. Nevertheless, there remains no effective medication or intervention been approved in postoperative delirium. Recent research suggests that continuous theta burst stimulation (cTBS) has shown positive effect on improving global cognitive function in multiple mental disorders. However, the effects on cognitive function in postoperative delirium remain uninvestigated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Age = 65 years;

2. Being scheduled to undergo an elective surgery (=3 hours, general anesthesia) (e.g., hip replacement or open reduction with internal fixation surgery for the repair of hip fractures);

3. Being able to complete cognitive assessment and confusion assessment methods (CAM);

4. Having normal cognitive function at the time of enrollment, e.g., Mini-Mental State Examination (MMSE) scores above 24;

5. Chinese Mandarin as the native language;

6. Willing to participate and being competent to provide informed consent.

Exclusion Criteria:

1. Having preoperative delirium assessed by CAM;

2. Having brain tumor, stroke, or mental disorders (e.g., depression or dementia);

3. Having contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head or heart);

4. Participating in other clinical studies.

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium
• Transcranial Magnetic Stimulation, Repetitive

Intervention

Device:
• Continuous theta burst stimulation (cTBS)
Our active treatment will 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. All enrolled patient in the cTBS group will receive 1 set simulation per day with an intersession interval (ISI) of over 30 minutes during the hospitalization after the surgery. The first set of stimulation will be given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation will be given at 8 am, 8:30 am and 9:00 am on postoperative day 1,2 and 3, respectively.
• Sham stimulation
The sham stimulation group will receive a sham cTBS (600 pulses per session, 3 sessions per day, ISI = 30mins, 4 days) with the coil set at 90 against the skull. The first set of stimulation will be given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation will be given at 8 am, 8:30 am and 9:00 am on postoperative day 1,2 and 3, respectively.

Locations

Country	Name	City	State
China	Shanghai 10th People's Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital	Massachusetts General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium	Incidence of postoperative delirium on postoperative day 1, 2 and 3 will be defined according to the confusion assessment methods (CAM).	3 days after surgery
Primary	Cognitive function related to delirium	The cognitive function related to delirium will be assessed by using Delirium Symptom Interview Daily (DSI Daily).	3 days after surgery
Primary	Severity of postoperative delirium	Severity of postoperative delirium on postoperative day 1, 2 and 3 will be defined according to he Confusion Assessment Method based delirium severity evaluation tool (CAM-S).The sum score of CAM-S ranges from 0 (no) to 19 (most severe).	3 days after surgery
Secondary	Pain level	This will be assessed by using Visual Analogue Scale (VAS). The patients scored according to the severity of their pain from no pain (0) to most painful (10).	up to 7 days after anesthesia/surgery
Secondary	Sleep quality	This will be assessed by using Pittsburgh Sleep Quality Index (PSQI).The global PSQI score ranges from 0 to 21, where lower scores denote a healthier sleep quality.	up to 7 days after anesthesia/surgery
Secondary	Ability of daily living	This will be assessed by using Chinese version of Activity of Daily Living (ADL) Scale.The total score of ADLs ranges from 14 to 56 points and higher ADLs scores indicate lower activities of daily living.	up to 7 days after anesthesia/surgery
Secondary	Rate of complication and mortality	Rate of complication and mortality during the stay in hospital or up to 7 days after anesthesia/surgery, depending which one is longer	up to 7 days after anesthesia/surgery