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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorKorea University Anam Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • repetitive transcranial magnetic stimulation

    Device

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: 10HzExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Week 12

Secondary outcomes

1

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)

Time frame
Week 12
2

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)

Time frame
Week 12
3

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)

Time frame
Week 12
4

Clinical Global Impression

Assessing overall treatment response. CGI-I: 1-7 (1 = very much improved, 7 = very much worse)

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.