Mild Cognitive Impairment (MCI)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
low-intensity focused ultrasound applied with a two element transducer from sonic concepts.
DEVICESham (No Treatment)
Blocked LIFU
Sponsors
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Blocked LIFU to the same brain region will be utilized during the sham condition.
Intervention model description
sham controlled with two groups (real and sham LIFU) - with the randomized split between real and sham being 2:1.
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Montreal Cognitive Assessment (MoCA) scores between 18-23 inclusive, and able to consent to their own medical care.
Exclusion criteria
* Claustrophobia * MRI contraindications (pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, or other implants) * CT contraindications (pregnancy) * Non-AD etiology (eg. Lewy body disease, vascular dementia, alcohol/drug related damage) * Taking anti-amyloid antibodies * Neuromod within 6 months of the study * History of other neurological disorder * Hx of head injury with LOC \> 10 min * Active alcohol or drug dependence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of LIFU in MCI patients - Report of Symptoms Assessment | Throughout study participation - about 6 months in total. | 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. |
| Tolerability Questionnaire Data | 30 minutes after the intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects on cognitive function using MoCA. | 4 times over the course of study participation - which is about 6 months in total. | 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. |
Countries
United States
Outcome results
None listed