NCT03574207 Targeted Transcranial Magnetic Stimulation to Improve Hippocampal-dependent Declarative Memory Abilities
| NCT ID | NCT03574207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nebraska |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2019-01-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a pilot study of non-invasive transcranial magnetic stimulation (TMS) to improve memory in healthy adults. It will also examine treating memory deficits in older adults with amnestic mild cognitive impairment (aMCI), a condition that frequently precedes Alzheimer's disease (AD). The study will test whether a form of non-invasive brain stimulation repetitive transcranial magnetic stimulation (rTMS) can improve memory abilities in healthy young adults, healthy older adults, and older adults with aMCI by retuning memory-related brain networks. This study is a key first step which will support the long-term goal of treating memory deficits in neurological patients. It is expected that rTMS will improve memory abilities in all participants, and that the improvements in memory will be attributable to changes in the connectivity of memory-related brain networks.
Eligibility Criteria
The investigators anticipate enrolling 48 subjects total: * 16 healthy young adults (age 19-35) * 16 healthy older adults (demographically matched to aMCI group for age, sex, and educational attainment) * 16 older adults diagnosed with amnestic mild cognitive impairment (aMCI) Inclusion Criteria: 1. Adults 19 years of age and older 2. Healthy adults without history of psychiatric or neurological disease OR previous diagnosis of amnestic MCI 3. Must be able to provide informed consent 4. Must have the ability to comply with basic instructions and have the ability to sit comfortably still for TMS, neuroimaging, and other study procedures. 5. Right-handed based on self-report (pre-screening) and evaluation with a standard test. Exclusion Criteria: 1. Individuals who have ferrous metal implanted in their body (other than in their teeth) or any other non-removable medical and/or metallic implant 2. Individuals who have increased intracranial pressure 3. Individuals who have any major medical illness (e.g., cancer, HIV+, hepatitis, heart disease) 4. Individuals who have confounding/dual diagnoses (e.g., comorbid mental illness and substance use disorder) 5. Individuals with current diagnoses of alcohol or substance abuse/dependence 6. Individuals with epilepsy, any history of seizures, or using medication that lowers seizure threshold 7. Individuals with any neurological disorder other than aMCI (e.g., stroke, traumatic brain injury) 8. Pregnant females --- as determined by urine pregnancy test --- will be excluded from this study due to uncertainty of the effects of MRI and TMS on the fetus 9. Not right-handed based on self-report (pre-screening) or evaluation with a standard test 10. Not a native English speaker.
Contact & Investigator
David E Warren, PhD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT03574207 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03574207 currently recruiting?
Yes, NCT03574207 is actively recruiting participants. Contact the research team at wnl@unmc.edu for enrollment information.
Where is the NCT03574207 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT03574207 clinical trial?
NCT03574207 is sponsored by University of Nebraska. The principal investigator is David E Warren, PhD at University of Nebraska. The trial plans to enroll 80 participants.