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Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

Primary Purpose

Postoperative Delirium, Transcranial Magnetic Stimulation, Repetitive

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continuous theta burst stimulation (cTBS)
Sham stimulation
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium focused on measuring postoperative delirium, continuous theta burst stimulation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai 10th People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

cTBS group

sham group

Arm Description

Patients randomly assigned to cTBS group will receive 12 sessions cTBS for total four days after surgery.

Patients randomly assigned to sham group will receive 12 sessions sham stimulation for total four days after surgery.

Outcomes

Primary Outcome Measures

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).
Cognitive function related to delirium
The cognitive function related to delirium will be assessed by using Delirium Symptom Interview Daily (DSI Daily).
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).

Secondary Outcome Measures

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).
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.
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.
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

Full Information

First Posted
November 26, 2020
Last Updated
April 20, 2021
Sponsor
Shanghai 10th People's Hospital
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04661904
Brief Title
Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium
Official Title
Effect of Continuous Theta Burst Stimulation (cTBS) on Postoperative Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2021 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
Collaborators
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium, Transcranial Magnetic Stimulation, Repetitive
Keywords
postoperative delirium, continuous theta burst stimulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cTBS group
Arm Type
Experimental
Arm Description
Patients randomly assigned to cTBS group will receive 12 sessions cTBS for total four days after surgery.
Arm Title
sham group
Arm Type
Sham Comparator
Arm Description
Patients randomly assigned to sham group will receive 12 sessions sham stimulation for total four days after surgery.
Intervention Type
Device
Intervention Name(s)
Continuous theta burst stimulation (cTBS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of postoperative delirium
Description
Incidence of postoperative delirium on postoperative day 1, 2 and 3 will be defined according to the confusion assessment methods (CAM).
Time Frame
3 days after surgery
Title
Cognitive function related to delirium
Description
The cognitive function related to delirium will be assessed by using Delirium Symptom Interview Daily (DSI Daily).
Time Frame
3 days after surgery
Title
Severity of postoperative delirium
Description
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).
Time Frame
3 days after surgery
Secondary Outcome Measure Information:
Title
Pain level
Description
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).
Time Frame
up to 7 days after anesthesia/surgery
Title
Sleep quality
Description
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.
Time Frame
up to 7 days after anesthesia/surgery
Title
Ability of daily living
Description
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.
Time Frame
up to 7 days after anesthesia/surgery
Title
Rate of complication and mortality
Description
Rate of complication and mortality during the stay in hospital or up to 7 days after anesthesia/surgery, depending which one is longer
Time Frame
up to 7 days after anesthesia/surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 65 years; 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); Being able to complete cognitive assessment and confusion assessment methods (CAM); Having normal cognitive function at the time of enrollment, e.g., Mini-Mental State Examination (MMSE) scores above 24; Chinese Mandarin as the native language; Willing to participate and being competent to provide informed consent. Exclusion Criteria: Having preoperative delirium assessed by CAM; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Shen, MD, PhD
Phone
2166303649
Email
kmshy@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongyong Shi, MD
Phone
18701915271
Email
szy0721@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Shen, MD, PhD
Organizational Affiliation
Shanghai, Shanghai, China, 200072
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34400453
Citation
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.
Results Reference
derived

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Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

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