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UnknownNCT03896698

Feasibility Study of Transcranial Ultrasound Stimulation on Alzheimer's Disease Patients

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
National Yang Ming Chiao Tung University · Academic / Other
Sex
All
Age
55 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Currently, the main treatment method for Alzheimer's disease (AD) is chemotherapy. However, the effectiveness of drugs is moderate and there are several side effects. In this clinical trial, the investigators would like to activate the brain by the transcranial ultrasound stimulation (TUS). This is a feasibility study to evaluate the safety and initial effectiveness of TUS for the treatment of patients with mild AD.

Detailed description

The purpose of this study is to verify the feasibility of low intensity transcranial ultrasound stimulation (TUS) for patients with mild Alzheimer's disease (AD). As a secondary aim, the investigators will explore whether the TUS is associated with improvement in cognitive functioning six and forty-six weeks following the intervention. Subjects will be randomly assigned to one of two experimental groups which with or without the TUS administration. The investigators will study up to 20 subjects with mild AD. Initially, subjects will undergo a screening assessment with a study physician to determine medical and psychiatric history, establish AD diagnosis, and undergo a bold draw. Subjects that meet criteria and agree to participate in the study will undergo a follow-up visit. In the baseline measurement visit, participants will first undergo neuropsychological testing. Participants will be randomly assigned to one of two groups. Participants will then be administrated TUS treatment for six weeks. Subsequently, participants will undergo a series of neuropsychological test. A final follow-up assessment will be administered at forty-six weeks.

Conditions

Interventions

TypeNameDescription
DEVICETranscranial Ultrasound StimulationTUS activate the brain cells

Timeline

Start date
2019-08-23
Primary completion
2021-05-31
Completion
2021-06-30
First posted
2019-04-01
Last updated
2020-04-28

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT03896698. Inclusion in this directory is not an endorsement.