Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05448768
• Other study ID #: 202102037A3A0
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Subjects aged 50-90 year

2. Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)

3. The CDR of MCI patients can be 0-0.5

4. Amyloid PET should ever be performed

Exclusion Criteria:

1. Any subject has a definite diagnosis of epilepsy or history of seizure attack.

2. Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.

3. 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.

4. 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.

5. Any females who is pregnant or lactating.

6. 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

1. Complications onset after intervention that affect efficacy and safety judgments.

2. New onset or progression of disease that may affect outcomes.

3. Use of other therapies or drugs during the intervention period to change cognitive functions.

4. Any subjects who are recognized as high risk of adverse effects by principle investigator.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• TBS for Amyloid-positive MCI
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.
• TBS for Amyloid-negative MCI
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination ( MMSE )	Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention	Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS
Primary	Montreal Cognitive Assessment	Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention	Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS
Secondary	The standard uptake values changes of FDG-PET	The standard uptake values (SUV) changes of cerebral glucose metabolism using 18F-FDG-PET	Before and immediately after TBS intervention