Parkinson Disease Clinical Trial
Official title:
The Use of Transcranial Focused Ultrasound for the Treatment of Neurodegenerative Dementias
Verified date | March 2023 |
Source | Neurological Associates of West Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with mild cognitive impairment or dementia.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | January 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 93 Years |
Eligibility | Inclusion Criteria: - CDR stage of at least 0.5 (mild cognitive impairment) - At least one pathognomic imaging biomarker of a neurodegenerative process. Exclusion Criteria: - Cognitive decline clearly related to an acute illness - Subjects unable to give informed consent - Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer) - Advanced terminal illness - Advanced kidney, pulmonary, cardiac or liver failure - Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep - Subjects with major depressive disorder - Subjects with vascular causes of dementia |
Country | Name | City | State |
---|---|---|---|
United States | Neurological Associates of West LA | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Neurological Associates of West Los Angeles |
United States,
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* Note: There are 44 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quick Dementia Rating Scale | The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). | Baseline | |
Secondary | Repeatable Battery Assessment for Neuropsychological Status (RBANS) | RBANS assesses immediate memory, visuospatial skill, language, attention, and delayed memory. Patient performance on each subscale immediate memory, language, attention, visuospatial, and delayed memory are scored relative to validated norms for same-aged peers. A change of 8+ points in the Total Scale score, 11+ points in the Immediate Memory score, 9+ points in the Language score, 4+ points on the Attention score, 14+ points is considered significant for the Visuospatial score, and 10+ points for the Delayed Memory score are considered significant. | Baseline | |
Secondary | Repeatable Battery Assessment for Neuropsychological Status (RBANS) | RBANS assesses immediate memory, visuospatial skill, language, attention, and delayed memory. Patient performance on each subscale immediate memory, language, attention, visuospatial, and delayed memory are scored relative to validated norms for same-aged peers. A change of 8+ points in the Total Scale score, 11+ points in the Immediate Memory score, 9+ points in the Language score, 4+ points on the Attention score, 14+ points is considered significant for the Visuospatial score, and 10+ points for the Delayed Memory score are considered significant. | After final ultrasound (8 weeks from baseline) | |
Secondary | Montreal Cognitive Assessment (MoCA) | The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status. | Baseline | |
Secondary | Montreal Cognitive Assessment (MoCA) | The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status. | After final ultrasound (8 weeks from baseline) | |
Secondary | Quick Dementia Rating Scale (QDRS) | The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). | After final ultrasound (8 weeks from baseline) |
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