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

Primary Purpose

Mild Cognitive Impairment, Memory Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Cognitive Impairment

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Nebraska Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm A: Stimulation then Sham

Arm B: Sham then Stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in intrinsic functional connectivity between the target brain region stimulated with rTMS and other brain regions.
The investigators will use MRI and MEG to measure brain function before and after treatment to determine whether brain function differs as a result of treatment.

Full Information

First Posted
May 31, 2018
Last Updated
October 9, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT03574207
Brief Title
Targeted Transcranial Magnetic Stimulation to Improve Hippocampal-dependent Declarative Memory Abilities
Official Title
Targeted Transcranial Magnetic Stimulation to Improve Hippocampal-dependent Declarative Memory Abilities
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators propose a pilot study of the potential for non-invasive transcranial magnetic stimulation (TMS) to improve memory in healthy adults (young and old) and to treat memory deficits in older adults with amnestic mild cognitive impairment (aMCI). aMCI is a condition that frequently precedes Alzheimer's disease (AD), and a key symptom of aMCI is clinically significant memory loss (i.e., rapid forgetting) greater than expected for age. The investigators 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's specific aims are to: 1) Measure changes in declarative memory performance after treatment with targeted rTMS; 2) Measure modulation of functional brain networks after treatment with targeted rTMS. To achieve these aims, the investigators will recruit participants from a standing registry and other sources, test their memory abilities, apply rTMS to a specific brain region, and then test their memory abilities again. As a control, all participants will receive sham rTMS that does not stimulate the brain in one of the two phases of participation. By testing whether real rTMS improves memory abilities more than sham rTMS, the investigators will determine whether rTMS can reliably improve memory in the populations of interest. Also, the investigators will measure changes in brain activity before and after stimulation using magnetic resonance imaging (MRI) and magnetoencephalography (MEG). This study is a key first step which will support the investigators' long-term goal of treating memory deficits in neurological patients. The investigators expect 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. This study has clear clinical and translational relevance because it adapts a novel technique addressing a key symptom of AD to new populations. The investigators expect that the findings will improve the field's understanding of memory loss in healthy aging, aMCI, and AD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Memory Loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Stimulation then Sham
Arm Type
Other
Arm Description
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.
Arm Title
Arm B: Sham then Stimulation
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in memory performance measured with the number of studied face-word associations recalled
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Changes in intrinsic functional connectivity between the target brain region stimulated with rTMS and other brain regions.
Description
The investigators will use MRI and MEG to measure brain function before and after treatment to determine whether brain function differs as a result of treatment.
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Christopher-Hayes
Phone
402-559-5805
Email
wnl@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Warren, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David E Warren, PhD
Phone
402-559-5805
Email
david.warren@unmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators have not yet determined whether or how data may be shared with other researchers.

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

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