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Enrolling by Invitation

NCT Number: NCT07691918

Mild Cognitive Impairment and Neuromodulation

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Intensity Focused Ultrasound

Device

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

Other names: tFUS, FUS

Sham (No Treatment)

Device

Blocked LIFU

Primary outcomes

  1. Safety of LIFU in MCI patients - Report of Symptoms Assessment

    Time frame: 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.

  2. Tolerability Questionnaire Data

    Time frame: 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 outcomes

  1. Effects on cognitive function using MoCA.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

MCI - Mild Cognitive Impairment and Neuromodulation

Acronym: MCI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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