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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lewy Body Dementia
• Intervention / Treatment: Device: Transcranial low intensity focused ultrasound stimulation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Penghu Wei, doctor; Phone Number: 18601986863; Email: weipenghu@xwhosp.org

Study Locations

• China
  • Beijing, China, 100053
    • Xuanwu Hospital, Capital Medical University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: active stimulus group; Patients were assigned into active stimulus group according to random number table	Device: Transcranial low intensity focused ultrasound stimulation; Low intensity focused transcranial ultrasound stimulation can safely and effectively regulate neuron excitability through mechanical force.; Other Names: tFUS
SHAM_COMPARATOR: sham stimulus control group; Patients were assigned into sham stimulus control group according to random number table	Device: Transcranial low intensity focused ultrasound stimulation; Low intensity focused transcranial ultrasound stimulation can safely and effectively regulate neuron excitability through mechanical force.; Other Names: tFUS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2026
• Study Completion (ANTICIPATED): November 1, 2026

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (ACTUAL): August 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Lewy Body Disease
• Other Study ID Numbers: [2022]110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No