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

NCT05499429 | Not Yet Recruiting DMC

• 1 other identifier: [2022]110
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lewy Body Dementia

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression Scale

  Evaluate the improvement of clinical symptoms.

  12 weeks

Secondary Outcomes (2)

• resting EEG

  12 weeks

• head MRI

  12 weeks

Study Arms (2)

active stimulus group

ACTIVE COMPARATOR

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

Device: Transcranial low intensity focused ultrasound stimulation

sham stimulus control group

SHAM COMPARATOR

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

Device: Transcranial low intensity focused ultrasound stimulation

Interventions

Transcranial low intensity focused ultrasound stimulation DEVICE

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

Also known as: tFUS

active stimulus group; sham stimulus control group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University.

Beijing, 100053, China

Location

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Penghu Wei, doctor

CONTACT

18601986863; weipenghu@xwhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: August 12, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)