The Effects of Intermittent Theta Burst Stimulation in MCI and Early AD
Cognitive Effects of Theta Burst Stimulation in Mild Cognitive Impairment and Alzheimer's Disease
1 other identifier
interventional
54
1 country
1
Brief Summary
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technique that is increasingly used for a growing number of research and clinical applications.Typically, this transient magnetic field is focally applied with a figure-of-eight coil that is carefully placed on the surface of the scalp over a targeted stimulation site. Patterned repetitive TMS (rTMS), such as theta burst stimulation (TBS) can produce long-lasting effects on neural activity and behavior beyond the stimulation period (Chou et al., 2015a; Fitzgerald et al., 2006). In general, high frequency (\> 5 Hz) rTMS and its newer version, intermittent theta burst stimulation (iTBS), facilitate cortical excitability, whereas low frequency (about 1 Hz) rTMS and continuous theta burst stimulation contribute to opposite effects (Pascual-Leone et al., 2000; Huang et al., 2005; Wassermann and Zimmermann, 2012).Careful manipulation of the parameters comprising these patterned rTMS pulse trains can induce neuroplastic changes that resemble either long-term potentiation (LTP) or depression (Chen et al., 1997; Pascual-Leone et al., 1994). Early studies targeting the motor cortex helped elucidate which rTMS parameters promote particular responses and their neurophysiological underpinnings (Klomjai et al., 2015). In recent years, rTMS has been closely investigated to evaluate its potential to modulate cognitive functions in Alzheimer'sdisease (AD) and mild cognitive impairment (MCI). As compared to conventional excitatory rTMS protocols, iTBS leads to comparable effects with similar number of pulses but considerable shorter duration and lower intensity of stimulation (Bakker et al., 2015; Rossi, Hallett, Rossini, Pascual-Leone, \& Safety, 2009). Recent literature also suggest that TBS has lower rates of reported adverse event (AE) compared to rTMS (Najib \& Horvath, 2014). Therefore, iTBS is assumed to modulate cognitive function in people with cognitive impairments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedStudy Start
First participant enrolled
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedOctober 26, 2022
October 1, 2022
1.3 years
August 25, 2020
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes from baseline in scores of any tests of the Neuropsychological Battery
WAIS-IV short-form, Word Sequence Learning Test, Benton Visual Retention Test, Color Trial Tests, 3-D Dimensional Constructional Test, Visual Confrontation Naming, Semantic Verbal Fluency Test, Stroop Color-Word Test
Baseline, immediate post-iTBS, follow-up (4 weeks post-iTBS)
Secondary Outcomes (1)
Brain MRI
Baseline, immediate post-iTBS, follow-up (4 weeks post-iTBS)
Study Arms (2)
active iTBS
EXPERIMENTALThe patient is treated with iTBS stimulation according to protocol with an active coil.
Sham iTBS
SHAM COMPARATORThe patient is treated with Sham-iTBS stimulation according to protocol with an inactive coil.
Interventions
active or Sham iTBS will be given to the AD/MCI patient
Eligibility Criteria
You may qualify if:
- normal visual acuity
- diagnosed with mild cognitive impairment or early dementia due to Alzheimer's disease (CDR = 0.5) by neurologists
You may not qualify if:
- (family) history of seizure attacks
- in intensive care
- history of drug/alcohol dependence
- assistants or students of the PI
- major systemic diseases concerning cognitive decline (e.g., cardiopulmonary failure, liver/renal failure, poor controlled DM, traumatic brain injury, stroke, or other neurodegenerative diseases)
- claustrophobia
- metal implants
- taking medication lowering the threshold of seizure attacks
- fear of using TMS
- with specific allergens
- pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shuang Ho Hospital
New Taipei City, Taiwan
Related Publications (1)
Yang CC, Huang KY, Hsu JL, Hu CJ, Lu YH, Kuan YC. Effects of intermittent theta-burst stimulation on cognition and glymphatic system activity in mild cognitive impairment and very mild Alzheimer's disease: a randomized controlled trial. J Neuroeng Rehabil. 2025 Sep 26;22(1):195. doi: 10.1186/s12984-025-01738-1.
PMID: 41013466DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Chun Kuan, MD
Taipei Medical University Shuang Ho Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The participant and principal investigator do not know what treatment is applied. The outcomes assessor will also be blinded. Only the co-PI who perform the TMS will know the stimulation condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical researcher
Study Record Dates
First Submitted
August 25, 2020
First Posted
September 21, 2020
Study Start
October 5, 2020
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
October 26, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share