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

NCT ID: NCT05499429

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2026-11-30

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.

Conditions

Lewy Body Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

active stimulus group

Patients were assigned into active stimulus group according to random number table

Group Type: ACTIVE_COMPARATOR

Transcranial low intensity focused ultrasound stimulation

Intervention Type: DEVICE

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

sham stimulus control group

Patients were assigned into sham stimulus control group according to random number table

Group Type: SHAM_COMPARATOR

Transcranial low intensity focused ultrasound stimulation

Intervention Type: DEVICE

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

Interventions

Transcranial low intensity focused ultrasound stimulation

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

Intervention Type: DEVICE

Other Intervention Names

tFUS

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University.

Beijing, , China

Countries

China

Central Contacts

Penghu Wei, doctor

Role: CONTACT

weipenghu@xwhosp.org

18601986863

Other Identifiers

[2022]110

Identifier Type: -

Identifier Source: org_study_id