Mild Cognitive ImpairmentNCT05448768
Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI
A study testing TBS for Amyloid-positive MCI and TBS for Amyloid-negative MCI in people with Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- TBS for Amyloid-positive MCI and TBS for Amyloid-negative MCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Sep 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 50-90 year
- Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)
- The CDR of MCI patients can be 0-0.5
- Amyloid PET should ever be performed
Who cannot join
- Any subject has a definite diagnosis of epilepsy or history of seizure attack.
- Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
- Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.
- Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse.
- Any females who is pregnant or lactating.
- General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body.
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- Withdrawal criteria
- Complications onset after intervention that affect efficacy and safety judgments.
- New onset or progression of disease that may affect outcomes.
- Use of other therapies or drugs during the intervention period to change cognitive functions.
- Any subjects who are recognized as high risk of adverse effects by principle investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biomarker-based Prediction of Cognitive Effects and Potential Mechanisms of Theta-burst Stimulation (TBS) in Subjects With Mild Cognitive Impairment (MCI)
This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI).
Read the detailed description
The investigators apply the NIA-AA criteria to subtype different endophenotypes of biomarker-defined MCI individuals. This is a prospective, open-label clinical trial, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 80 MCI patients will be consecutively recruited and be subjected to iTBS for 5 daily interventions per week for two consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.
- Conditions
- Mild Cognitive Impairment
- Being tested
- TBS for Amyloid-positive MCI, TBS for Amyloid-negative MCI
- Keywords
- Mild Cognitive Impairment, theta-burst stimulation, repetitive transcranial magnetic stimulation (rTMS)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBS for Amyloid-positive MCIDevice
The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.
TBS for Amyloid-negative MCIDevice
The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Amyloid-positive MCI | Active comparator | The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol. Receives: Device: TBS for Amyloid-positive MCI |
| Amyloid-negative MCI | Active comparator | The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol. Receives: Device: TBS for Amyloid-negative MCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination ( MMSE )
Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention
Measured: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS
Montreal Cognitive Assessment
Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention
Measured: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS
Secondary outcomes (1)
The standard uptake values changes of FDG-PET
The standard uptake values (SUV) changes of cerebral glucose metabolism using 18F-FDG-PET
Measured: Before and immediately after TBS intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start13 Sep 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, we will give two sessions of iTBS separated by 15 min.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KUAN YI WU, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448768
- Sponsor's protocol ID
- 202102037A3A0
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker-based Prediction of Cognitive Effects and Potential Mechanisms of Theta-burst Stimulation (TBS) in Subjects With Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT05448768
- Acronym / sponsor ID
- 202102037A3A0
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, theta-burst stimulation, repetitive transcranial magnetic stimulation (rTMS)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI).
Detailed description
The investigators apply the NIA-AA criteria to subtype different endophenotypes of biomarker-defined MCI individuals. This is a prospective, open-label clinical trial, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 80 MCI patients will be consecutively recruited and be subjected to iTBS for 5 daily interventions per week for two consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, we will give two sessions of iTBS separated by 15 min.
| Arm | Type | Receives |
|---|---|---|
| Amyloid-positive MCI | Active comparator | Device: TBS for Amyloid-positive MCIThe subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol. |
| Amyloid-negative MCI | Active comparator | Device: TBS for Amyloid-negative MCIThe subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 50-90 year
- Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)
- The CDR of MCI patients can be 0-0.5
- Amyloid PET should ever be performed
Key exclusion criteria (11 listed)
- Any subject has a definite diagnosis of epilepsy or history of seizure attack.
- Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
- Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.
- Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse.
- Any females who is pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBS for Amyloid-positive MCIThe investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min. | Device | Amyloid-positive MCI |
| TBS for Amyloid-negative MCIThe investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min. | Device | Amyloid-negative MCI |
Primary outcome
Mini-Mental State Examination ( MMSE )
Time frame: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS
Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention
Montreal Cognitive Assessment
Time frame: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS
Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention
1 secondary outcome
The standard uptake values changes of FDG-PET
Time frame: Before and immediately after TBS intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
KUAN YI WU principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TBS for Amyloid-positive MCI and TBS for Amyloid-negative MCI in people with Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination ( MMSE ) (time frame: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.