Objective: To investigate the safety and potential cognitive benefits of repetitive transcranial magnetic stimulation (rTMS) in patients with dementia with Lewy bodies (DLB) using a 12-week treatment protocol.

Background: There is currently no established disease-modifying treatment for DLB, and symptomatic treatment options remain limited. Non-invasive brain stimulation, including rTMS, has shown potential benefit in other neurodegenerative disorders, but its role in DLB has not been systematically studied.

Method: This ongoing proof-of-concept, single-arm clinical study enrolls patients who meet the 2017 consensus criteria for probable DLB. Eligible participants are aged 65 years or older and have a Clinical Dementia Rating (CDR) of 0.5–1.0. Baseline electroencephalography and magnetic resonance imaging are performed to exclude alternative causes of cognitive impairment. Phosphene threshold is determined using single-pulse TMS before treatment initiation. The intervention consists of an induction phase of three sessions per week for 2 weeks, followed by a maintenance phase of one session per week for 10 weeks. Each session delivers 1,600 pulses over 20 minutes at 10 Hz with 4-second trains and 26-second inter-train intervals, using the Brain Hi ATNC-MDD V2 stimulator and ATNC-BN-V1 neuronavigation system. The primary endpoint is change in CDR-Sum of Boxes from baseline to week 12. Secondary outcomes include changes in Mini-Mental State Examination, Korean version of the Montreal Cognitive Assessment, Caregiver-Administered Neuropsychiatric Inventory, Clinical Global Impression, and Patient’s Global Impression. Safety is assessed through adverse event monitoring.

Results: To date, six patients have been enrolled, and four have completed treatment and follow-up assessments. No adverse events have been observed among these participants. Final data collection is expected to be completed by May 2026.

Conclusion: This ongoing study is designed to provide preliminary evidence regarding the safety, feasibility, and potential cognitive benefits of rTMS in DLB. Interim findings suggest that rTMS is well tolerated, with no safety concerns identified to date. Final analyses will help clarify its therapeutic potential and inform future controlled trials.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-feasibility-of-repetitive-transcranial-magnetic-stimulation-in-dementia-with-lewy-bodies-an-ongoing-proof-of-concept-study/