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Enrolling by invitation NCT05448768

Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TBS for Amyloid-positive MCI, TBS for Amyloid-negative MCI.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: 50 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • Device 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.

Primary outcome measures

  • Mini-Mental State Examination ( MMSE ) [Time frame: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS]
  • Montreal Cognitive Assessment [Time frame: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS]
Secondary outcome measures (1)
  • The standard uptake values changes of FDG-PET [Time frame: Before and immediately after TBS intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital — Taoyuan

Identifiers

NCT: NCT05448768 · 202102037A3A0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗