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

Lewy Body Dementia Clinical Trial

— tFUS in DLB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05499429
• Other study ID #: [2022]110
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: November 2026

Study information

• Verified date: August 2022
• Source: Xuanwu Hospital, Beijing
• Contact: Penghu Wei, doctor
• Phone: 18601986863
• Email: weipenghu[@]xwhosp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dementia
• Lewy Body Dementia
• Lewy Body Disease

Intervention

Device:
• Transcranial low intensity focused ultrasound stimulation
Low intensity focused transcranial ultrasound stimulation can safely and effectively regulate neuron excitability through mechanical force.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University.	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

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