RecruitingPhase 1Phase 2NCT07122908

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


Sponsor

Korea University Anam Hospital

Enrollment

10 participants

Start Date

Apr 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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.

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Interventions

DEVICErepetitive transcranial magnetic stimulation

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


Locations(1)

Korea University Anam Hospital

Seoul, Seoul, South Korea

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NCT07122908


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