iTBS in MCI and Mild AD
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: Active rTMS, Sham rTMS.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI), Mild Alzheimer Disease. Basic parameters: 50 years — 85 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 →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Device Active rTMS
iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions - Device Sham rTMS
sham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions
Primary outcome measures
- 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]
Secondary outcome measures (3)
- 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).]
- 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).]
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Tri-Service General Hospital — Taipei
Publications
- Daskalakis ZJ. Theta-burst transcranial magnetic stimulation in depression: when less may be more. Brain. 2014 Jul;137(Pt 7):1860-2. doi: 10.1093/brain/awu123. Epub 2014 May 15. No abstract available. PMID 24833712
- Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. PMID 15664172
Identifiers
NCT: NCT06670820 · A202305164