Targeted Transcranial Magnetic Stimulation to Improve Hippocampal-dependent Declarative Memory Abilities

NCT03574207 | Recruiting FDA Device

• 1 other identifier: 0096-18-FB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Memory Loss

Outcome Measures

Primary Outcomes (1)

• Changes in memory performance measured with the number of studied face-word associations recalled

  The investigators will measure memory performance before and after treatment to determine whether performance differs as a result of treatment. The main task will be a face-word association task in which participants will study a list of faces paired with single words. After a short delay, one studied face will be presented at a time, and participants will be prompted to recall the word associated with the face. The number of correct face-word associations recalled is the dependent measure.

  Potential changes will be assessed after each one-week rTMS treatment period. Results will be reported at the end of the study (approximately one year).

Secondary Outcomes (1)

• Changes in intrinsic functional connectivity between the target brain region stimulated with rTMS and other brain regions.

  Potential changes will be assessed after each one-week rTMS treatment period. Results will be reported at the end of the study (approximately one year).

Study Arms (2)

Arm A: Stimulation then Sham

OTHER

All procedures are identical in both arms with the exception of the order of stimulation administration. In Arm A, transcranial magnetic stimulation (TMS) will be applied in the first week of participation, and sham stimulation will be applied in the second week of participation.

Device: Transcranial magnetic stimulation

Arm B: Sham then Stimulation

OTHER

All procedures are identical in both arms with the exception of the order of stimulation administration. In Arm B, sham stimulation will be applied in the first week of participation, and transcranial magnetic stimulation (TMS) will be applied in the second week of participation.

Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation DEVICE

Transcranial magnetic stimulation non-invasively applies very small amounts of electrical current to brain tissue; sham stimulation uses the same approach but applies little or no actual stimulation to the brain by using less power or greater distance between the head and the stimulator.

Arm A: Stimulation then Sham; Arm B: Sham then Stimulation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 19 years of age and older
• Healthy adults without history of psychiatric or neurological disease OR previous diagnosis of amnestic MCI
• Must be able to provide informed consent
• Must have the ability to comply with basic instructions and have the ability to sit comfortably still for TMS, neuroimaging, and other study procedures.
• Right-handed based on self-report (pre-screening) and evaluation with a standard test.

You may not qualify if:

• Individuals who have ferrous metal implanted in their body (other than in their teeth) or any other non-removable medical and/or metallic implant
• Individuals who have increased intracranial pressure
• Individuals who have any major medical illness (e.g., cancer, HIV+, hepatitis, heart disease)
• Individuals who have confounding/dual diagnoses (e.g., comorbid mental illness and substance use disorder)
• Individuals with current diagnoses of alcohol or substance abuse/dependence
• Individuals with epilepsy, any history of seizures, or using medication that lowers seizure threshold
• Individuals with any neurological disorder other than aMCI (e.g., stroke, traumatic brain injury)
• 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
• Not right-handed based on self-report (pre-screening) or evaluation with a standard test
• Not a native English speaker.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• David E Warren, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Wilhelm, MA

CONTACT

402-559-5805; wnl@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 29, 2018
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)