Mild Cognitive Impairment and Neuromodulation

NCT07691918 | Enrolling By Invitation FDA Device

• 1 other identifier: 26-461
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Effects on cognitive function using MoCA.

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

Study Arms (2)

Real LIFU

EXPERIMENTAL

Active Low Intensity Focused Ultrasound application

Device: Low intensity focused ultrasound

Sham LIFU

SHAM COMPARATOR

Blocked LIFU energy to the same brain region as the active group.

Device: Sham (No Treatment)

Interventions

Low intensity focused ultrasound DEVICE

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

Also known as: tFUS, FUS

Real LIFU

Sham (No Treatment) DEVICE

Blocked LIFU

Sham LIFU

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Montreal Cognitive Assessment (MoCA) scores between 18-23 inclusive, and able to consent to their own medical care.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blocked LIFU to the same brain region will be utilized during the sham condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: sham controlled with two groups (real and sham LIFU) - with the randomized split between real and sham being 2:1.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)