Mild Cognitive Impairment Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Bioscience Research Laboratory | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Brain imaging data | The investigators will acquire MRI images to measure structural and functional connectivity, respectively. | an average of 1 month | |
Other | Brain imaging data | The investigators will acquire MRI images to measure structural and functional connectivity, respectively. | 3 months after the intervention phase complete | |
Other | NACC Neuropsychological batteries | The investigators will use Neuropsychological batteries, which would calculate the Z-score, for measuring cognitions function. With Z-score, the investigators can classify participants into MCI or non-MCI group. | an average of 1 month | |
Other | NACC Neuropsychological batteries | The investigators will use Neuropsychological batteries, which would calculate the Z-score, for measuring cognitions. With Z-score, the investigators can classify participants into MCI or non-MCI group. | 3 months after the intervention phase complete | |
Other | Correction rate in memory association recall | Memory tasks will be implemented and measure the correct rate to assess memory function. | an average of 1 month | |
Other | Correction rate in memory association recall | Memory tasks will be implemented and measure the correct rate to assess memory function. | 3 months after the intervention phase complete | |
Primary | Brain imaging data | The investigators will acquire MRI images to measure structural and functional connectivity, respectively. | Baseline | |
Primary | NACC Neuropsychological batteries | The investigators will use Neuropsychological batteries, which would calculate the Z-score, for measuring cognitions. With Z-score, the investigators can classify participants into MCI or non-MCI group. | Baseline | |
Primary | Correction rate in memory association recall | Memory tasks will be implemented and measure the correct rate to assess memory function. | Baseline | |
Primary | Specimen sample | A specimen for DNA will be collected and determine whether participants have APOE genotype. | 1 day (Only once in the beginning phase) | |
Secondary | Brain imaging data | The investigators will acquire MRI images to measure structural and functional connectivity, respectively. | 2 weeks after the intervention phase begin | |
Secondary | Correction rate in memory association recall | Memory tasks will be implemented and measure the correct rate to assess memory function. | 2 weeks after the intervention phase begin |
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