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Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

Primary Purpose

Postoperative Delirium, Continuous Theta Burst Stimulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous theta burst stimulation (cTBS)
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Delirium

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    postoperative delirium

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    February 4, 2022
    Last Updated
    February 4, 2022
    Sponsor
    RenJi Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05239897
    Brief Title
    Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation
    Official Title
    Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation: an Exploratory Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 7, 2022 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RenJi 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 determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Delirium, Continuous Theta Burst Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    postoperative delirium
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Continuous theta burst stimulation (cTBS)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Cure rate of POD after a single cTBS treatment
    Description
    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.
    Time Frame
    7 days after surgery
    Secondary Outcome Measure Information:
    Title
    Cure rate of POD after multiple cTBS treatments
    Description
    No POD was evaluated by CAM at 1 hour after two or three cTBS treatments and at any time point thereafter.
    Time Frame
    7 days after surgery
    Title
    Severity of postoperative delirium changed after each cTBS treatment
    Description
    Severity of postoperative delirium on postoperative day 1 to 7 will be defined according to MDAS.
    Time Frame
    7 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diansan Su
    Phone
    +86 18616514088
    Email
    diansansu@yahoo.com

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Postoperative Delirium With Continuous Theta Burst Stimulation

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