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

Not Applicable

Not yet recruiting

• Conditions: Lewy Body Dementia
• Interventions: Device: Transcranial low intensity focused ultrasound stimulation

• Registration Number: NCT05499429
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-07-14
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Study First Posted: 2022-08-12
• Last Update Posted: 2022-08-12
• Study Start: 2022-09
• Primary Completion: 2026-01
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham stimulus control group	Transcranial low intensity focused ultrasound stimulation	Patients were assigned into sham stimulus control group according to random number table
active stimulus group	Transcranial low intensity focused ultrasound stimulation	Patients were assigned into active stimulus group according to random number table

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression Scale	12 weeks	Evaluate the improvement of clinical symptoms.

Secondary Outcome Measures

Name	Time	Method
resting EEG	12 weeks	EEG power in alpha band
head MRI	12 weeks	Changes of brain function by fMRI

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University.; 🇨🇳 Beijing, China