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

Primary Purpose

Lewy Body Dementia

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Transcranial low intensity focused ultrasound stimulation

About this trial

This is an interventional treatment trial for Lewy Body Dementia

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Xuanwu Hospital, Capital Medical University.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active stimulus group

sham stimulus control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical Global Impression Scale

Evaluate the improvement of clinical symptoms.

Secondary Outcome Measures

resting EEG

EEG power in alpha band

head MRI

Changes of brain function by fMRI

Full Information

NCT ID

NCT05499429

First Posted

July 14, 2022

Last Updated

August 10, 2022

Sponsor

Xuanwu Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT05499429

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lewy Body Dementia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients were randomly assigned to the active stimulation group and sham stimulation group.

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

Patients were randomly assigned to the active stimulation group and sham stimulation group, Patients，Care Provider and Outcomes Assessor did not know the patient grouping.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

active stimulus group

Arm Type

Active Comparator

Arm Description

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

Arm Title

sham stimulus control group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Transcranial low intensity focused ultrasound stimulation

Other Intervention Name(s)

tFUS

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical Global Impression Scale

Description

Evaluate the improvement of clinical symptoms.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

resting EEG

Description

EEG power in alpha band

Time Frame

12 weeks

Title

head MRI

Description

Changes of brain function by fMRI

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Penghu Wei, doctor

Phone

18601986863

weipenghu@xwhosp.org

Facility Information:

Facility Name

Xuanwu Hospital, Capital Medical University.

City

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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