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This is a parallel, sham-controlled design of low-intensity focused ultrasound in patients with mild cognitive impairment (MCI). The study will evaluate safety, tolerability, and effects on cognitive function.
This parallel 2 arm study is sham controlled and collected over 6 study visits. Participants will receive MRI and CT scans, LIFU neuromodulation, cognitive assessments, and questionnaires batteries to assess tolerability and functional outcomes in an MCI population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real LIFU | Experimental | Active Low Intensity Focused Ultrasound application |
|
| Sham LIFU | Sham Comparator | Blocked LIFU energy to the same brain region as the active group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity focused ultrasound | Device | low-intensity focused ultrasound applied with a two element transducer from sonic concepts. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of LIFU in MCI patients - Report of Symptoms Assessment | Symptom data (each possible symptom is listed & scored on a likert scale - absent, mild, moderate, or severe. Free response section for any symptoms not listed.) collected before and during a follow-up period after LIFU application. Questionnaire data to be completed directly by the subject. | Throughout study participation - about 6 months in total. |
| Tolerability Questionnaire Data | Participants complete a questionnaire at the end of the study visit to query if they were uncomfortable/comfortable (on a likert scale, strongly disagree to strongly agree) during the experiment and if they would suggest the study to others. This data will be used to analyze tolerability of the study visits in this clinical population. | 30 minutes after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on cognitive function using MoCA. | The Montreal Cognitive Assessment (MoCA) will be performed at 4 time points throughout the participation in this study. This is used to assess any changes in cognitive processing - it evaluates memory, executive function, language, attention, and orientation. Assessment produces a score up to 30. 26 and above are considered cognitively normal. Between 19 and 25, a patient is considered to have mild cognitive impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute at VTC | Roanoke | Virginia | 24016 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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sham controlled with two groups (real and sham LIFU) - with the randomized split between real and sham being 2:1.
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Blocked LIFU to the same brain region will be utilized during the sham condition.
| Sham (No Treatment) | Device | Blocked LIFU |
|
| 4 times over the course of study participation - which is about 6 months in total. |