iTBS in MCI and Mild AD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorNational Defense Medical Center, Taiwan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
History of stroke
History of uncontrol seizure
History of significant head trauma followed by persistent neurologic deficit or known structural brain abnormality
Mental illness
Trial design
Design model
Crossover
Treatments tested in this trial
Active rTMS
DeviceiTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions
Sham rTMS
Devicesham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Active iTBS for Patients With MCI or ADActive comparator 0 interventions
Group B: Sham iTBS for Patients With MCI or ADSham comparator 1 intervention
Trial outcomes
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.
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.
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 treatmentSecondary 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.
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.
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).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.Sponsors and contacts
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Source ClinicalTrials.gov
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