Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06670820

iTBS in MCI and Mild AD

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Alzheimer Disease Neurocognitive Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, Other, 114, Taiwan

Location contact

Yu-Kai Lin

CONTACT

[email protected]

886-2-87923311 ext 10552,13907

CONTACT

886-987-859-907

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active rTMS

Device

iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions

sham rTMS

Device

sham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

YU-KAI LIN

CONTACT

[email protected]

886-987-859-907

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.