Dementia With Lewy BodiesPhase 1/2NCT07122908
The Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive Improvement in Dementia With Lewy Bodies
A Phase 1/2 study testing repetitive transcranial magnetic stimulation in people with Dementia With Lewy Bodies, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
This study aimed to investigate the feasibility of repetitive transcranial magnetic stimulation (rTMS) on the occipital lobe in patients with Lewy body dementia. This is a proof-of-concept study to evaluate the safety and effect of occipital lobe stimulation in patients with Lewy body dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2024to Dec 2026
- Phase
- Phase 1/2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Over 65 years of age
- Meeting the criteria for Probable DLB as proposed in the 2017 DLB diagnostic criteria
- Scoring between 0.5 and 1 on the Clinical Dementia Rating Scale (CDR)
Who cannot join
- If other causes of cognitive impairment are suspected, such as neurosyphilis, hypothyroidism, hyperthyroidism, metabolic encephalopathy, brain tumor, acute cerebral hemorrhage, acute cerebral infarction, previous territorial or strategic cerebral infarction, Wernicke's encephalopathy, or severe white matter hyperintensity detected in hematological tests, brain MRI, etc.
- If cooperation for interviews and self-assessment is difficult (e.g., due to hearing impairment, language disorders, severe psychotic conditions)
- If there is a history of psychiatric disorders: major affective disorder, schizophrenia, or schizo-affective disorder
- If electroencephalography (EEG) cannot be performed
- If epileptiform EEG findings are present or if the patient is currently receiving antiepileptic drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, Seoul, 02841
Kyougnwon Baik, MD, phD, +82-02-920-6287, baikkw@kumc.or.kr
About this study
This study aimed to investigate the feasibility of repetitive transcranial magnetic stimulation (rTMS) on the occipital lobe in patients with Lewy body dementia.
This is a proof-of-concept study to evaluate the safety and effect of occipital lobe stimulation in patients with Lewy body dementia. Over a period of two weeks, participants will receive rTMS to the primary visual cortex three times a week during visits. For the remaining 10 weeks, maintenance therapy will be administered with rTMS once a week during visits. Efficacy assessments will be conducted on the day of the final stimulation session and again four weeks later.
Read the detailed description
This is a proof-of-concept, single-arm clinical study investigating the safety and potential cognitive benefits of repetitive transcranial magnetic stimulation (rTMS) in patients with dementia with Lewy bodies (DLB). All enrolled participants will receive active rTMS, delivered at 10 Hz over the primary visual cortex.
Following screening based on the 2017 criteria for probable DLB, eligible patients (aged ≥65 years, with a Clinical Dementia Rating [CDR] between 0.5 and 1.0) will undergo baseline EEG (Electroencephalography) and MRI (Magnetic resonance imaging) to exclude other causes of cognitive impairment. A single-pulse TMS session will be used to determine the phosphene threshold. rTMS sessions will then commence, with stimulation administered three times per week for 2 weeks (induction phase), followed by once-weekly sessions for 10 weeks (maintenance phase). Each rTMS session will deliver 1,600 pulses over 20 minutes (10 Hz frequency, 4-second trains with 26-second inter-train intervals).
Primary efficacy will be evaluated based on change in CDR-SOB (Clinical Dementia Rating - Sum of Boxes) from baseline to the end of treatment (week 12). Secondary outcomes include changes in MMSE (Mini-Mental State Examination), K-MOCA (Korean version of the Montreal Cognitive Assessment), CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory), CGI (Clinical Global Impression), PGI (Patient's Global Impression). Assessments will be conducted at baseline, immediately after the last treatment session, and at a 4-week follow-up. Safety will be evaluated through adverse event monitoring, categorized by severity and relation to the intervention.
The intervention device is the Brain Hi ATNC-MDD V2 magnetic stimulator, used in conjunction with the ATNC-BN-V1 neuronavigation system. Devices will be managed by trained technicians throughout the study.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- repetitive transcranial magnetic stimulation
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
10Hz stimulation group will receive 1600 pulses of stimulation in a single session
| Study group | Role | What they receive |
|---|---|---|
| 10Hz | Experimental | Not described Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of boxes of the clinical dementia rating scale
The Clinical Dementia Rating - Sum of Boxes (CDR-SOB) is a quantitative scale used to assess the severity of cognitive and functional impairment in individuals with dementia. It is derived from the Clinical Dementia Rating (CDR), which evaluates six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
Each domain is rated on a scale from 0 (no impairment) to 3 (severe impairment), and the scores are summed to produce the CDR-SOB, which ranges from 0 to 18. Unlike the global CDR score, the CDR-SOB provides a more sensitive measure of changes in cognitive and functional performance over time, making it especially useful for tracking disease progression in clinical trials and longitudinal studies.
Measured: Week 12
Secondary outcomes (5)
Mini-Mental State Examination
A brief 30-point cognitive screening tool that assesses orientation, memory, attention, calculation, language, and visuospatial skills. 0-30 (higher = better cognition)
Measured: Week 12
Korean version of the Montreal Cognitive Assessment
A more sensitive 30-point cognitive screening test than MMSE, used to detect mild cognitive impairment; assesses memory, executive function, attention, language, and visuospatial skills. 0-30 (higher = better cognition)
Measured: Week 12
Caregiver-Administered Neuropsychiatric Inventory
A caregiver-based questionnaire evaluating behavioral and psychiatric symptoms in dementia across 12 domains (e.g., delusions, hallucinations, agitation). 0-144 (higher = worse symptoms; frequency × severity per domain)
Measured: Week 12
Clinical Global Impression
Assessing overall treatment response. CGI-I: 1-7 (1 = very much improved, 7 = very much worse)
Measured: Week 12
Patient's Global Impression
Patient's self-rating of their perception of change in overall health status after treatment. 1-7 (1 = very much improved, 7 = very much worse)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start11 Apr 2024
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoungwon Baik, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122908
- Sponsor's protocol ID
- 2024AN0178
- Status last verified
- Aug 2025
- First submitted
- 28 May 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to regulation of institutional IRB
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive Improvement in Dementia With Lewy Bodies
- ClinicalTrials.gov ID
- NCT07122908
- Acronym / sponsor ID
- 2024AN0178
- Conditions
- Dementia With Lewy Bodies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Aug 2025 (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 aimed to investigate the feasibility of repetitive transcranial magnetic stimulation (rTMS) on the occipital lobe in patients with Lewy body dementia.
This is a proof-of-concept study to evaluate the safety and effect of occipital lobe stimulation in patients with Lewy body dementia. Over a period of two weeks, participants will receive rTMS to the primary visual cortex three times a week during visits. For the remaining 10 weeks, maintenance therapy will be administered with rTMS once a week during visits. Efficacy assessments will be conducted on the day of the final stimulation session and again four weeks later.
Detailed description
This is a proof-of-concept, single-arm clinical study investigating the safety and potential cognitive benefits of repetitive transcranial magnetic stimulation (rTMS) in patients with dementia with Lewy bodies (DLB). All enrolled participants will receive active rTMS, delivered at 10 Hz over the primary visual cortex.
Following screening based on the 2017 criteria for probable DLB, eligible patients (aged ≥65 years, with a Clinical Dementia Rating [CDR] between 0.5 and 1.0) will undergo baseline EEG (Electroencephalography) and MRI (Magnetic resonance imaging) to exclude other causes of cognitive impairment. A single-pulse TMS session will be used to determine the phosphene threshold. rTMS sessions will then commence, with stimulation administered three times per week for 2 weeks (induction phase), followed by once-weekly sessions for 10 weeks (maintenance phase). Each rTMS session will deliver 1,600 pulses over 20 minutes (10 Hz frequency, 4-second trains with 26-second inter-train intervals).
Primary efficacy will be evaluated based on change in CDR-SOB (Clinical Dementia Rating - Sum of Boxes) from baseline to the end of treatment (week 12). Secondary outcomes include changes in MMSE (Mini-Mental State Examination), K-MOCA (Korean version of the Montreal Cognitive Assessment), CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory), CGI (Clinical Global Impression), PGI (Patient's Global Impression). Assessments will be conducted at baseline, immediately after the last treatment session, and at a 4-week follow-up. Safety will be evaluated through adverse event monitoring, categorized by severity and relation to the intervention.
The intervention device is the Brain Hi ATNC-MDD V2 magnetic stimulator, used in conjunction with the ATNC-BN-V1 neuronavigation system. Devices will be managed by trained technicians throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10Hz | Experimental | Device: repetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Over 65 years of age
- Meeting the criteria for Probable DLB as proposed in the 2017 DLB diagnostic criteria
- Scoring between 0.5 and 1 on the Clinical Dementia Rating Scale (CDR)
Key exclusion criteria (5 listed)
- If other causes of cognitive impairment are suspected, such as neurosyphilis, hypothyroidism, hyperthyroidism, metabolic encephalopathy, brain tumor, acute cerebral hemorrhage, acute cerebral infarction, previous territorial or strategic cerebral infarction, Wernicke's encephalopathy, or severe white matter hyperintensity detected in hematological tests, brain MRI, etc.
- If cooperation for interviews and self-assessment is difficult (e.g., due to hearing impairment, language disorders, severe psychotic conditions)
- If there is a history of psychiatric disorders: major affective disorder, schizophrenia, or schizo-affective disorder
- If electroencephalography (EEG) cannot be performed
- If epileptiform EEG findings are present or if the patient is currently receiving antiepileptic drugs.
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation10Hz stimulation group will receive 1600 pulses of stimulation in a single session | Device | 10Hz |
Primary outcome
Sum of boxes of the clinical dementia rating scale
Time frame: Week 12
The Clinical Dementia Rating - Sum of Boxes (CDR-SOB) is a quantitative scale used to assess the severity of cognitive and functional impairment in individuals with dementia. It is derived from the Clinical Dementia Rating (CDR), which evaluates six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a scale from 0 (no impairment) to 3 (severe impairment), and the scores are summed to produce the CDR-SOB, which ranges from 0 to 18. Unlike the global CDR score, the CDR-SOB provides a more sensitive measure of changes in cognitive and functional performance over time, making it especially useful for tracking disease progression in clinical trials and longitudinal studies.
5 secondary outcomes
Mini-Mental State Examination
Time frame: Week 12
Korean version of the Montreal Cognitive Assessment
Time frame: Week 12
Caregiver-Administered Neuropsychiatric Inventory
Time frame: Week 12
Clinical Global Impression
Time frame: Week 12
Patient's Global Impression
Time frame: Week 12
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 14 Aug 2025.
- Individual participant dataSharing planned: No. Due to regulation of institutional IRB
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing repetitive transcranial magnetic stimulation in people with Dementia With Lewy Bodies, run by Korea University Anam Hospital at 1 site in South Korea.
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 3 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. 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 South Korea. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kyoungwon Baik, MD, PhD (+8229205510, baikkw88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of boxes of the clinical dementia rating scale (time frame: Week 12). 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 14 Aug 2025.