Mild Cognitive Impairment (MCI)NCT06670820
iTBS in MCI and Mild AD
A study testing Active rTMS in people with Mild Cognitive Impairment (MCI) and Mild Alzheimer Disease, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Mild Alzheimer Disease
- What is being tested?
- Active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2024to 31 Dec 2028
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Tri-Service General Hospital
Taipei, Other, 114
Yu-Kai Lin, 886-2-87923311 ext 10552,13907, yukai0907@ndmctsgh.edu.tw
886-987-859-907
About this study
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
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.
- Being tested
- Active rTMS, Sham rTMS
- Keywords
- rTMS, iTBS, Mild Cognitive Impairment, Mild Alzheimer Disease
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions
Sham rTMSDevice
sham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS for Patients With MCI or AD | Active comparator | The patient will receive one daily rTMS session for 10 days of iTBS, delivered through an H-coil applied to the left dorsolateral prefrontal cortex. The TBS frequency parameters consist of 3-pulse 50-Hz bursts every 200 ms at 5 Hz, and the intensity will be set at 80% of the active motor threshold (AMT). A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. |
| Sham iTBS for Patients With MCI or AD | Sham comparator | Sham stimulation will be delivered 10 sessions. Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (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.
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.
Measured: 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
Measured: 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.
Measured: Side effects will be monitored during 2 groups (active and sham) through study completion, an average of 3-4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start31 Oct 2024 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Kai Lin, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670820
- Sponsor's protocol ID
- A202305164
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 24833712Huang 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.
PubMed 15664172
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06670820
- Acronym / sponsor ID
- A202305164
- Keywords
- rTMS, iTBS, Mild Cognitive Impairment, Mild Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Nov 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active iTBS for Patients With MCI or AD | Active comparator | –The patient will receive one daily rTMS session for 10 days of iTBS, delivered through an H-coil applied to the left dorsolateral prefrontal cortex. The TBS frequency parameters consist of 3-pulse 50-Hz bursts every 200 ms at 5 Hz, and the intensity will be set at 80% of the active motor threshold (AMT). A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. |
| Sham iTBS for Patients With MCI or AD | Sham comparator | Device: Sham rTMSSham stimulation will be delivered 10 sessions. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Active rTMSiTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions | Device | – |
| Sham rTMSsham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions | Device | Sham iTBS for Patients With MCI or AD |
Primary outcome
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.
3 secondary outcomes
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.
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 1 Nov 2024.
- Results publication: PubMed 24833712Daskalakis 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.
- Results publication: PubMed 15664172Huang 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Mild Cognitive Impairment (MCI)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Active, not recruiting
EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS in people with Mild Cognitive Impairment (MCI) and Mild Alzheimer Disease, run by National Defense Medical Center, Taiwan 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Nov 2024. 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. Some participants in this study may receive a placebo. 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?
Contact YU-KAI LIN (886-987-859-907, yukai0907@ndmctsgh.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06670820, which also lists 2 linked publications.
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 1 Nov 2024.