Mild Cognitive Impairment and Neuromodulation

N/AEnrolling By InvitationNCT07691918

Virginia Polytechnic Institute and State University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Mild Cognitive Impairment (MCI)

Interventions

Low intensity focused ultrasoundDEVICE

low-intensity focused ultrasound applied with a two element transducer from sonic concepts.

Sham (No Treatment)DEVICE

Blocked LIFU

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 minutes after the intervention

Secondary Outcomes

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.

Time frame: 4 times over the course of study participation - which is about 6 months in total.

Data from ClinicalTrials.gov

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