RECRUITING

Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

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Conditions

Alzheimer Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.

Official Title

Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Quick Facts

Study Start:2023-10-12
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05997030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and non-pregnant females, aged 45-85 years
  2. * Able and willing to give informed consent
  3. * Must meet the clinical criteria for MCI due to Alzheimer's disease
  4. * If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
  5. * Able to communicate sensations during the LIFU procedure
  1. * Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
  2. * Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
  3. * Participants with a history of seizure disorder.
  4. * Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
  5. * Participant does not speak English
  6. * Participant is pregnant or planning to be pregnant

Contacts and Locations

Study Contact

Marc Haut, PhD
CONTACT
3042934816
mhaut@hsc.wvu.edu
Kiley Everson
CONTACT
3042931316
kiley.everson@hsc.wvu.edu

Principal Investigator

Ali Rezai
PRINCIPAL_INVESTIGATOR
WVU Rockefeller Neuroscience Institute

Study Locations (Sites)

Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505
United States

Collaborators and Investigators

Sponsor: Ali Rezai

  • Ali Rezai, PRINCIPAL_INVESTIGATOR, WVU Rockefeller Neuroscience Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-12
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-10-12
Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer Disease