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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Single-center Randomized Controlled Trial of Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia

Conditions
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Lewy Body Dementia

Intervention / Treatment
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* Device: Transcranial low intensity focused ultrasound stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomly assigned to the active stimulation group and sham stimulation group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active stimulus group<br>Patients were assigned into active stimulus group according to random number table | Device: Transcranial low intensity focused ultrasound stimulation<br>* Low intensity focused transcranial ultrasound stimulation can safely and effectively regulate neuron excitability through mechanical force.<br>* Other names: tFUS;|
| Sham Comparator: sham stimulus control group<br>Patients were assigned into sham stimulus control group according to random number table | Device: Transcranial low intensity focused ultrasound stimulation<br>* Low intensity focused transcranial ultrasound stimulation can safely and effectively regulate neuron excitability through mechanical force.<br>* Other names: tFUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale | Evaluate the improvement of clinical symptoms. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting EEG | EEG power in alpha band | 12 weeks | 
| head MRI | Changes of brain function by fMRI | 12 weeks |