Feasibility Study of Transcranial Ultrasound Stimulation on Alzheimer's Disease Patients (TUS)
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|ClinicalTrials.gov Identifier: NCT03896698|
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Device: Transcranial Ultrasound Stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility Study of Transcranial Ultrasound Stimulation on Alzheimer's Disease Patients|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: TUS treatment
AD patients with TUS treatment
Device: Transcranial Ultrasound Stimulation
TUS activate the brain cells
No Intervention: Non-TUS treatment
AD patients with Non-TUS treatment
- Device and procedure related adverse events recording [ Time Frame: up to 46 weeks after treatment ]Rate of adverse events following each treatment through end of study Clinical and MRI evaluation
- Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) [ Time Frame: Change from baseline at 7, 12, 24, and 52 week ]ADAS was designed to measure the severity of the most important symptoms of Alzheimer's disease (AD). Its subscale ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The test administrator adds up points for the errors in each task of the ADAS-Cog for a total score. Total scores range from 0-70. The greater the dysfunction, the greater the score.
- Clinical Dementia Rating (CDR) [ Time Frame: Change from baseline at 12 and 52 week ]The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage'). Using a structured-interview protocol, qualified health professional assesses a patient's cognitive and functional performance in six areas: memory, orientation, judgment & problem solving, community affairs, home & hobbies, and personal care. Scores in each of these are combined to obtain a composite score ranging from 0 through 3, with 0 meaning of no symptoms, 0.5 very mild dementia, 1 mild dementia, 2 moderate dementia and 3 severe dementia.
- Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Change from baseline at 12 and 52 week ]NPI-Q is a carer-based tool that assesses the possible presence of 12 symptoms in dementia cases, including delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, night-time behavioral disturbances and appetite/eating disturbances. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress). The total scores of severity and caregiver stress are summed of each 12 items separately, with with higher scores indicating a greater number of neuropsychiatric symptoms or distress.
- Transcranial Doppler (TCD) [ Time Frame: Changes in blood flow from baseline at 12 and 52 week ]Cerebral blood flow evaluation
- Magnetic Resonance Image (MRI) [ Time Frame: Change from baseline at 12 and 52 week ]Brain observation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896698
|Contact: Jong-Ling Fuh, M.D.||firstname.lastname@example.org|
|Contact: Feng-Yi Yang, Ph.D.||email@example.com|
|Taipei Veterans General Hospital||Not yet recruiting|
|Contact: Jong-Ling Fuh, M.D.|
|Principal Investigator: Jong-Li Fuh, M.D.|
|Principal Investigator:||Feng-Yi Yang, Ph.D.||National Yang Ming University|