NCT07122908 The Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive Improvement in Dementia With Lewy Bodies
| NCT ID | NCT07122908 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Korea University Anam Hospital |
| Condition | Dementia With Lewy Bodies |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-04-11 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-04-11 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07122908 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dementia With Lewy Bodies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07122908 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07122908 currently recruiting?
Yes, NCT07122908 is actively recruiting participants. Contact the research team at baikkw88@gmail.com for enrollment information.
Where is the NCT07122908 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07122908 clinical trial?
NCT07122908 is sponsored by Korea University Anam Hospital. The trial plans to enroll 10 participants.