Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium; Transcranial Magnetic Stimulation, Repetitive
• Intervention / Treatment: Device: Continuous theta burst stimulation (cTBS); Device: Sham stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Shen, MD, PhD; Phone Number: 2166303649; Email: kmshy@tongji.edu.cn
• Study Contact Backup: Name: Zhongyong Shi, MD; Phone Number: 18701915271; Email: szy0721@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Shanghai 10th People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cTBS group; Patients randomly assigned to cTBS group will receive 12 sessions cTBS for total four days after surgery.	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 Comparator: sham group; Patients randomly assigned to sham group will receive 12 sessions sham stimulation for total four days after surgery.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Yuan Shen, MD, PhD, Shanghai, Shanghai, China, 200072

Publications and helpful links

General Publications

• Wei X, Wang M, Ma X, Tang T, Shi J, Zhao D, Yuan T, Xie Z, Shen Y. Treatment of postoperative delirium with continuous theta burst stimulation: study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 16;11(8):e048093. doi: 10.1136/bmjopen-2020-048093.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2021
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: postoperative delirium; continuous theta burst stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: dsyy005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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