ITBS in MCI and Mild AD

October 31, 2024 updated by: Yu-Kai Lin, National Defense Medical Center, Taiwan

The Effects of Intermittent Theta-burst Stimulation on Cognitive Function in Patients with Mild Cognitive Impairment and Mild Alzheimer's Disease and the Role of Brain-Derived Neurotrophic Factor

This study aims to examine the effects of iTBS on cognitive function in individuals with MCI or mild AD, with a secondary objective of exploring prefrontal TBS mechanisms for cognitive function and the effect of iTBS on BDNF.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Other
      • Taipei, Other, Taiwan, 114
        • Tri-Service General Hospital
        • Contact:
        • Contact:
          • Phone Number: 886-987-859-907

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of MCI (overall Clinical Dementia Rating of 0.5)
  • Clinical diagnosis of mild Alzheimer's Disease (overall Clinical Dementia Rating of 0.5 or 1)

Exclusion Criteria:

  • History of stroke
  • History of uncontrol seizure
  • History of significant head trauma followed by persistent neurologic deficit or known structural brain abnormality
  • Mental illness
  • Drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active iTBS for Patients With MCI or AD
The patient will receive one daily rTMS session for 10 days of iTBS, delivered through an H-coil applied to the left dorsolateral prefrontal cortex. The TBS frequency parameters consist of 3-pulse 50-Hz bursts every 200 ms at 5 Hz, and the intensity will be set at 80% of the active motor threshold (AMT). A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times.
Device: Active rTMS
iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions
Sham Comparator: Sham iTBS for Patients With MCI or AD
Sham stimulation will be delivered 10 sessions.
Device: Sham rTMS
sham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in neurocognitive function test scores (Mini-Mental State Examination；MMSE) between T1 (Day 1) and T2 (Day 14), and the differences between the experimental and control groups.
Time Frame: MMSE will be controlled at baseline before active or sham rTMS, 2 weeks after active and sham rTMS, 3 months after the last treatment
The mini-mental state examination (MMSE) test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.The MMSE is a standardized cognitive screening test with a possible score of 0-30. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
MMSE will be controlled at baseline before active or sham rTMS, 2 weeks after active and sham rTMS, 3 months after the last treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in neurocognitive function test scores (Mini-Mental State Examination；MMSE) between T1(Day 1) and T3 (98 ± 14), and the differences between the experimental and control groups.
Time Frame: MMSE will be controlled at baseline (T1: Day 1) before active or sham rTMS, 2 weeks after active and sham rTMS (T2: Day 17 ± 5), 3 months after the last treatment (T3: Day 98 ± 14).
The mini-mental state examination (MMSE) test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.The MMSE is a standardized cognitive screening test with a possible score of 0-30. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
MMSE will be controlled at baseline (T1: Day 1) before active or sham rTMS, 2 weeks after active and sham rTMS (T2: Day 17 ± 5), 3 months after the last treatment (T3: Day 98 ± 14).
Changes in blood BDNF concentration levels before and after active rTMS and after sham rTMS, as well as the differences between the experimental group and the control group
Time Frame: BDNF will be controlled at baseline ( Day 1) before active or sham rTMS, 2 weeks after active and sham rTMS (Day 17 ± 5).
BDNF will be controlled at baseline ( Day 1) before active or sham rTMS, 2 weeks after active and sham rTMS (Day 17 ± 5).
Side effects between the two groups.
Time Frame: Side effects will be monitored during 2 groups (active and sham) through study completion, an average of 3-4 months.
Side effects will be monitored during 2 groups (active and sham) through study completion, an average of 3-4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defense Medical Center, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Estimated)

November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A202305164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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