The Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive Improvement in Dementia With Lewy Bodies

NCT07122908 | Recruiting Phase 1 DMC

• 1 other identifier: 2024AN0178
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dementia With Lewy Bodies

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (5)

• Mini-Mental State Examination

  Week 12

• Korean version of the Montreal Cognitive Assessment

  Week 12

• Caregiver-Administered Neuropsychiatric Inventory

  Week 12

• Clinical Global Impression

  Week 12

• Patient's Global Impression

  Week 12

Study Arms (1)

10Hz

EXPERIMENTAL

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation DEVICE

10Hz stimulation group will receive 1600 pulses of stimulation in a single session

10Hz

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Lewy Body Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Kyoungwon Baik, MD, PhD

CONTACT

+8229205510; baikkw88@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: August 14, 2025
• Study Start: April 11, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)