Mild Cognitive Impairment and Neuromodulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low intensity focused ultrasound, Sham (No Treatment).
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: 55 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MCI - Mild Cognitive Impairment and Neuromodulation
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.
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.
Interventions
- Device Low intensity focused ultrasound
low-intensity focused ultrasound applied with a two element transducer from sonic concepts. - Device Sham (No Treatment)
Blocked LIFU
Primary outcome measures
- Safety of LIFU in MCI patients - Report of Symptoms Assessment [Time frame: Throughout study participation - about 6 months in total.]
- Tolerability Questionnaire Data [Time frame: 30 minutes after the intervention]
Secondary outcome measures (1)
- Effects on cognitive function using MoCA. [Time frame: 4 times over the course of study participation - which is about 6 months in total.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fralin Biomedical Research Institute at VTC — Roanoke
Identifiers
NCT: NCT07691918 · 26-461