Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia

N/ANot Yet RecruitingNCT05499429

Xuanwu Hospital, Beijing20 enrolled

Overview

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.

This project plans to recruit 20 patients with mild Lewy body dementia.They were randomly divided into transcranial focused low-intensity ultrasound active stimulation group and sham stimulation group. Patients receive treatment three days a week, and the daily treatment time is 20-30 minutes.The duration of treatment is 4-12 weeks. Before treatment, cognitive assessment, resting EEG, head MRI and PET examination of glucose metabolism were completed.Complete the overall cognitive assessment, resting EEG and MRI examination within one week after the treatment, and complete the overall cognitive assessment and PET examination of glucose metabolism at the follow-up 6 months after the treatment.Fill in the treatment side effect scale and adverse event form.Keep the original oral drug dosage unchanged during the treatment process.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Lewy Body Dementia

Interventions

Transcranial low intensity focused ultrasound stimulationDEVICE

Low intensity focused transcranial ultrasound stimulation can safely and effectively regulate neuron excitability through mechanical force.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xuanwu Hospital, Capital Medical University.

Beijing, China

Outcomes

Primary Outcomes

Clinical Global Impression Scale

Evaluate the improvement of clinical symptoms.

Time frame: 12 weeks

Secondary Outcomes

resting EEG

EEG power in alpha band

Time frame: 12 weeks

head MRI

Changes of brain function by fMRI

Time frame: 12 weeks

Central Contacts

Penghu Wei, doctor

CONTACT

18601986863 weipenghu@xwhosp.org

Data from ClinicalTrials.gov

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