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Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

Primary Purpose

Mild Cognitive Impairment

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

TBS for Amyloid-positive MCI

TBS for Amyloid-negative MCI

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, theta-burst stimulation, repetitive transcranial magnetic stimulation (rTMS)

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects aged 50-90 year
Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)
The CDR of MCI patients can be 0-0.5
Amyloid PET should ever be performed

Exclusion Criteria:

Any subject has a definite diagnosis of epilepsy or history of seizure attack.
Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.
Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse.
Any females who is pregnant or lactating.
General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body.

Withdrawal criteria

Complications onset after intervention that affect efficacy and safety judgments.
New onset or progression of disease that may affect outcomes.
Use of other therapies or drugs during the intervention period to change cognitive functions.
Any subjects who are recognized as high risk of adverse effects by principle investigator.

Sites / Locations

Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Amyloid-positive MCI

Amyloid-negative MCI

Arm Description

The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol.

Outcomes

Primary Outcome Measures

Mini-Mental State Examination ( MMSE )

Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention

Montreal Cognitive Assessment

Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention

Secondary Outcome Measures

The standard uptake values changes of FDG-PET

The standard uptake values (SUV) changes of cerebral glucose metabolism using 18F-FDG-PET

Full Information

NCT ID

NCT05448768

First Posted

June 27, 2022

Last Updated

August 14, 2023

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05448768

Brief Title

Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

Official Title

Biomarker-based Prediction of Cognitive Effects and Potential Mechanisms of Theta-burst Stimulation (TBS) in Subjects With Mild Cognitive Impairment (MCI)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

September 13, 2022 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI).

Detailed Description

The investigators apply the NIA-AA criteria to subtype different endophenotypes of biomarker-defined MCI individuals. This is a prospective, open-label clinical trial, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 80 MCI patients will be consecutively recruited and be subjected to iTBS for 5 daily interventions per week for two consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment, theta-burst stimulation, repetitive transcranial magnetic stimulation (rTMS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, we will give two sessions of iTBS separated by 15 min.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Amyloid-positive MCI

Arm Type

Active Comparator

Arm Description

The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol.

Arm Title

Amyloid-negative MCI

Arm Type

Active Comparator

Arm Description

The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol.

Intervention Type

Device

Intervention Name(s)

TBS for Amyloid-positive MCI

Intervention Description

The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.

Intervention Type

Device

Intervention Name(s)

TBS for Amyloid-negative MCI

Intervention Description

The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.

Primary Outcome Measure Information:

Title

Mini-Mental State Examination ( MMSE )

Description

Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention

Time Frame

Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS

Title

Montreal Cognitive Assessment

Description

Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention

Time Frame

Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS

Secondary Outcome Measure Information:

Title

The standard uptake values changes of FDG-PET

Description

The standard uptake values (SUV) changes of cerebral glucose metabolism using 18F-FDG-PET

Time Frame

Before and immediately after TBS intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects aged 50-90 year Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999) The CDR of MCI patients can be 0-0.5 Amyloid PET should ever be performed Exclusion Criteria: Any subject has a definite diagnosis of epilepsy or history of seizure attack. Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor. Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders. Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse. Any females who is pregnant or lactating. General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body. Withdrawal criteria Complications onset after intervention that affect efficacy and safety judgments. New onset or progression of disease that may affect outcomes. Use of other therapies or drugs during the intervention period to change cognitive functions. Any subjects who are recognized as high risk of adverse effects by principle investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

KUAN YI WU

Organizational Affiliation

Chang Gung Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chang Gung Memorial Hospital

City

Taoyuan

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

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Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

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