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

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

This trial will try repetitive transcranial magnetic stimulation (rTMS) over the back of the head to see if it improves thinking and memory in people aged 65 and older with dementia with Lewy bodies.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Korea University Anam Hospital (Academic / other)
• Locations: 1 site (Seoul, Seoul)
• Trial ID: NCT07122908 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people aged 65 or older with probable DLB by 2017 diagnostic criteria and mild dementia (CDR 0.5–1.0) who can undergo MRI, EEG, and repeated in-person rTMS visits.

Not a fit: Patients with other suspected causes of cognitive decline, epileptiform EEG or active epilepsy, major psychiatric disorders, severe sensory or language barriers, or who cannot attend frequent clinic visits are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, this noninvasive approach could improve cognitive symptoms and daily functioning for some people with dementia with Lewy bodies.

How similar studies have performed: rTMS has produced mixed cognitive results in other dementia and psychiatric conditions, and occipital-targeted rTMS for DLB is a largely novel, unproven approach.

Eligibility criteria

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 this trial is running

Seoul, Seoul

• Korea University Anam Hospital — Seoul, Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Kyoungwon Baik, MD, PhD

Conditions Dementia With Lewy Bodies