Mild Cognitive Impairment (MCI)MCINCT07691918
Mild Cognitive Impairment and Neuromodulation
A study testing Low intensity focused ultrasound in people with Mild Cognitive Impairment (MCI), run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Low intensity focused ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Montreal Cognitive Assessment (MoCA) scores between 18-23 inclusive, and able to consent to their own medical care.
Who cannot join
- 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
Show all 9Show fewer
- History of other neurological disorder
- Hx of head injury with LOC > 10 min
- Active alcohol or drug dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: MCI - 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Low intensity focused ultrasound, Sham (No Treatment)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity focused ultrasoundDevice
Also called tFUS, FUS
low-intensity focused ultrasound applied with a two element transducer from sonic concepts.
Sham (No Treatment)Device
Blocked LIFU
| Study group | Role | What they receive |
|---|---|---|
| Real LIFU | Experimental | Active Low Intensity Focused Ultrasound application Receives: Device: Low intensity focused ultrasound |
| Sham LIFU | Sham comparator | Blocked LIFU energy to the same brain region as the active group. Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes after the intervention
Secondary outcomes (1)
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.
Measured: 4 times over the course of study participation - which is about 6 months in total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- sham controlled with two groups (real and sham LIFU) - with the randomized split between real and sham being 2:1.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wynn Legon, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691918
- Sponsor's protocol ID
- 26-461
- Acronym
- MCI
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MCI - Mild Cognitive Impairment and Neuromodulation
- ClinicalTrials.gov ID
- NCT07691918
- Acronym / sponsor ID
- MCI / 26-461
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- sham controlled with two groups (real and sham LIFU) - with the randomized split between real and sham being 2:1.
| Arm | Type | Receives |
|---|---|---|
| Real LIFU | Experimental | Device: Low intensity focused ultrasoundActive Low Intensity Focused Ultrasound application |
| Sham LIFU | Sham comparator | Device: Sham (No Treatment)Blocked LIFU energy to the same brain region as the active group. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Montreal Cognitive Assessment (MoCA) scores between 18-23 inclusive, and able to consent to their own medical care.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity focused ultrasoundAlso: tFUS, FUSlow-intensity focused ultrasound applied with a two element transducer from sonic concepts. | Device | Real LIFU |
| Sham (No Treatment)Blocked LIFU | Device | Sham LIFU |
Primary outcome
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.
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.
1 secondary outcome
Effects on cognitive function using MoCA.
Time frame: 4 times over the course of study participation - which is about 6 months in total.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity focused ultrasound in people with Mild Cognitive Impairment (MCI), run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of LIFU in MCI patients - Report of Symptoms Assessment (time frame: Throughout study participation - about 6 months in total.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.