Lewy Body Dementia Clinical Trial
— tFUS in DLBOfficial title:
Clinical Single-center Randomized Controlled Trial of Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia
A randomized controlled clinical study was conducted in the xuanwu hospital Single Center of Capital Medical University to preliminarily explore the efficacy and safety of transcranial focused low-intensity ultrasound stimulation in the treatment of dementia with Lewy bodies in the early stage, to clarify the effective mechanism and form an effective clinical treatment plan.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | November 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | Inclusion Criteria: - Male or female DLB patients between the ages of 50-85; - The psychological evaluation was in accordance with MMSE score of 18-24 (including 18 and 24) and CDR score of 0.5. - Can cooperate to complete clinical research. Exclusion Criteria: - There is a definite history of cerebrovascular stroke, and there are definite symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left by neuroimaging? - Those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment. - Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency). - Have a history of using antipsychotics for more than five years before diagnosis. - There are contraindications for head MRI examination. |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital, Capital Medical University. | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Global Impression Scale | Evaluate the improvement of clinical symptoms. | 12 weeks | |
Secondary | resting EEG | EEG power in alpha band | 12 weeks | |
Secondary | head MRI | Changes of brain function by fMRI | 12 weeks |
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