Magnetic stimulation of the visual cortex to try to improve thinking in dementia with Lewy bodies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm proof-of-concept study delivers active rTMS at 10 Hz to the primary visual cortex in participants aged 65+ who meet the 2017 criteria for probable dementia with Lewy bodies and have mild dementia (CDR 0.5–1.0). Baseline MRI and EEG are performed to exclude other causes of cognitive impairment and a single-pulse TMS session determines the phosphene threshold before treatment. The protocol uses an induction phase of three sessions per week for two weeks followed by once-weekly maintenance for 10 weeks, with each 20-minute session delivering 1,600 pulses (10 Hz, 4-second trains with 26-second inter-train intervals). Primary efficacy is change in CDR-SOB at week 12 with secondary outcomes including MMSE, K-MoCA, neuropsychiatric inventories, and global impression scales, plus an assessment four weeks after the final stimulation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Where it's running

• Korea University Anam Hospital
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Kyoungwon Baik, MD, PhD
• Email: baikkw88@gmail.com
• Phone: +8229205510

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.