Enhancement of Hippocampal Plasticity Using Repetitive Transcranial Magnetic Stimulation
The ultimate goal of this study is to develop non-invasive, painless repetitive transcranial magnetic stimulation (rTMS) protocols to prevent cognitive decline in patients with mild cognitive impairment (MCI) and cognitively normal individuals at high risk of developing Alzheimer's disease (AD). Currently, 1 in 9 adults over the age of 65 have AD, which currently totals more than 5 million Americans and this number is expected to rise as high as 16 million by 2050. MCI is a clinical syndrome that represents the gray area between healthy aging and dementia. Those with amnestic MCI (aMCI) have memory problems more severe than normal for their age and education, but their symptoms are not as severe as those of people with AD. Patients with aMCI are at high risk for AD. Notably, roughly half of those with MCI will continue to progress and convert to clinical dementia within 3 years. Alternatively, it is also worthwhile to study cognitively healthy older adults who carry genes that may increase the risk of AD. The frequency of the human APOE gene ε4 allele increases in patients with AD and the ε4 allele is also associated with an earlier age of disease onset. Currently, there are no known therapies that can effectively modify the progression and hallmark symptoms of AD. Therefore, it is crucial to provide an early intervention in patients with aMCI to delay or prevent the progression to AD. More specifically, this project has two specific aims: 1. To plan personalized non-invasive brain stimulation location by brain Imaging with Magnetic Resonance Imaging (MRI) in Mild Cognitive Impairment (MCI) 2. To identify potential personalized cognitive enhancement strategy (such as dosage or patterns) of Transcranial Magnetic Stimulation (TMS) in MCI. Techniques to artificially and precisely stimulate brain tissue are increasingly recognized as valuable tools both in clinical practice and in cognitive neuroscience studies among healthy individuals and people with clinical conditions. With these practices, researchers can safely stimulate specific regions of the brain to explore causal relationships that comprise the brain's circuitry and modulate behavior.
Conditions:
🦠 Mild Cognitive Impairment
🗓️ Study Start (Actual) 21 October 2020
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Tucson, Arizona, United States

📋 Eligibility Criteria

Description

  • Individuals with mild cognitive impairment (MCI Group)
  • Inclusion Criteria:

    • * Age 50-80 years
    • * MCI clinical criteria: (a) self- or informant-reported cognitive complaint; (b) preserved independence in functional abilities; and (c) absence of dementia.
    • * Objective cognitive impairment supported by the following measures of general cognitive function: (a) Mini-Mental State Exam (MMSE) 24-27 (inclusive); (b) Montreal Cognitive Assessment (MoCA) 18-26 (inclusive); or (c) Clinical Dementia Rating Scale score of 0.5.
    • * Right handed
    • * English speaking
    • * Able to attend daily intervention (Monday-Friday) for 4 weeks
    • * Not enrolled in another interventional study within 6 months prior to beginning this study

    Exclusion Criteria:

    • * Contraindications to transcranial magnetic stimulation (TMS) or magnetic resonance imaging (MRI)
    • * Other neurological disorders (e.g. stroke, head injuries, or multiple sclerosis)
    • * Untreated depression
    • * Current cancer treatment or other medical problems that might independently affect cognitive function
    • * Clinical Dementia Rating Scale score more than 1.0
Ages Eligible for Study: 50 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 14 January 2019
  • First Submitted that Met QC Criteria 23 May 2019
  • First Posted 24 May 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 December 2023
  • Last Update Posted 14 December 2023
  • Last Verified December 2023