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Mild Cognitive Impairment and Neuromodulation Study

This study is looking at a treatment called low-intensity focused ultrasound (LIFU) for people with mild cognitive impairment (MCI). LIFU uses sound waves to target specific areas of the brain. The study wants to see if LIFU is safe and well-tolerated, and if it affects how well people think. You might be able to join if you are between 55 and 80 years old and have a Montreal Cognitive Assessment (MoCA) score between 18 and 23. The study is comparing LIFU to a sham treatment (which means you wouldn't receive the active LIFU). We are currently enrolling about 40 participants.

Study design
This is a parallel, sham-controlled study, meaning participants will either receive LIFU or a sham treatment. It plans to enroll about 40 participants.
What's involved
You would have 6 study visits over approximately 6 months. These visits would include MRI and CT scans, receiving LIFU neuromodulation, cognitive assessments, and completing questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Safety will be assessed throughout study participation, which is about 6 months in total. Tolerability will be measured 30 minutes after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07691918

Mild Cognitive Impairment and Neuromodulation

Enrolling by Invitation
NAAges 55–80InterventionalTreatment
Virginia Polytechnic Institute and State University
~40 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Low intensity focused ultrasoundSham (No Treatment)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of LIFU in MCI patients - Report of Symptoms Assessment
Measured over Throughout study participation - about 6 months in total.
+1 more outcome measured

Conditions

Mild Cognitive Impairment (MCI)

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NCT07691918

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fralin Biomedical Research Institute at VTC

    Roanoke, Virginiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Safety of LIFU in MCI patients - Report of Symptoms AssessmentThroughout 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 Data30 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.