NCT05462782

Brief Summary

The aim of this study is to investigate the effects of Transcranial Magnetic Stimulation (TMS) following a Paired Associative Stimulation (PAS) protocol on the memorization capacity of elderly individuals. For this purpose, we will apply TMS synchronized with a working memory (WM) task and assess its effects on cortical connectivity and memorization capacity by Magnetic Resonance Imaging (MRI) and WM task learning. This study will be carried out in an older population of healthy participants. We will use the study results to refine the task related PAS protocol towards enhancing memory performance and brain connectivity.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

August 5, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

June 17, 2022

Last Update Submit

May 30, 2023

Conditions

Age-associated Memory Impairment

Keywords

Transcranial Magnetic StimulationPaired Associative StimulationWorking MemoryOlder adultsFunctional Magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

  • Changes in Working Memory (WM) capacity

    The WM task utilized is a customized version of the masking task model, presented by Sana Inoue and Tetsuro Matsuzawa, in 2007. This task is organized in three phases: 1) Waiting phase: a visual cue is presented to indicate the initiation of the trial; 2) Coding and retention phase: numbers are presented in a random arrangement within a 5x5 square matrix; and 3) Recall phase: the numbers disappear, leaving a white background as a clue, and the subject completes the task by pressing the squares in the matrix following the incremental order of the numbers. (Figure 2). The task ends either when the subject makes a mistake or completes correctly selecting all numbers in incremental order. The outcome measure for WM capacity is the amount of correctly remembered items (hit items) of each trial.

    Compared during each visit between baseline, immediately after the intervention, and 30 minutes after intervention

  • Changes in resting state functional MRI connectivity

    The neural connectivity index that we will assess responds to the strength of synaptic connections between neurons and over time. The identification of correlations between remote brain areas will be tested by resting state functional magnetic resonance imaging (rs-fMRI). We will compare the connectivity network after intervention time with baseline and sham group. Correlations of spontaneous modulations in the blood oxygen level dependent (BOLD) signal will be analyzed and regions with similar functional properties under resting conditions will be detected. This analysis is able to identify significant long-lasting effects of active stimulation (vs. sham) on brain connectivity.

    Compared during each visit between baseline and 30 minutes after intervention

Study Arms (2)

Active TMS

EXPERIMENTAL

Older healthy participants will be scanned with MRI and undergo memory task synchronized PAS with an active TMS in each visit with different stimulation localization and ISIs.

Device: Transcranial Magnetic Stimulation (TMS) Cone Coil

Sham TMS

SHAM COMPARATOR

Older healthy participants will be scanned with MRI and undergo memory task synchronized PAS with a sham TMS coil in each visit with different ISIs application.

Device: Transcranial Magnetic Stimulation (TMS) Sham Coil

Interventions

Transcranial Magnetic Stimulation (TMS) Cone CoilDEVICE

The cone coil Cool-DB80 (MagPro, MagVenture, Alpharetta GA, US) will be used with an MRI-based TMS navigation system (Localite, St Augustin, Germany). TMS interventions will involve the following parameters: 1. Hippocampal directed stimulation at ISI 0ms, 2. Hippocampal directed stimulation at ISI 200ms, 3. Motor cortex stimulation at ISI 0ms, and 4. Motor cortex stimulation at ISI 200ms.

Active TMS
Transcranial Magnetic Stimulation (TMS) Sham CoilDEVICE

The sham coil Cool B65 A/P (MagPro, MagVenture, Alpharetta GA, US) will be used with an MRI-based TMS navigation system (Localite, St Augustin, Germany). The different TMS interventions will be involve the following parameters: 1. Sham stimulation at ISI 0ms, and 2. Sham stimulation at ISI 200ms.

Sham TMS

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No history of a brain and/or skull lesion (e.g., stroke)
  • Normal vision (can be corrected)
  • Able to understand and give informed consent
  • No neurological disorders
  • Able to understand and speak English

You may not qualify if:

  • Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
  • Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
  • Surgical clips in the head or previous neurosurgery
  • Any magnetic particles in the body
  • Cochlear implants
  • Prosthetic heart valves
  • Epilepsy or any other type of seizure history
  • History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
  • Significant claustrophobia
  • Ménière's disease
  • Pregnancy or breast feeding
  • Non prescribed drug use
  • History of current substance abuse (exception: current nicotine use is allowed)
  • Marijuana
  • Any neurological diagnoses
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Jose L Pons, Ph.D

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the intervention conditions.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The purpose of this study is to understand how Transcranial Magnetic Stimulation(TMS) synchronized with a memory event can enhance working memory capacity. For this purpose, we will synchronize hippocampal directed stimulation, primary motor cortex stimulation and sham stimulation at Inter Stimulus Interval (ISI) 200 and 0 ms. The effects on memory will be assessed by a working memory task and resting state functional MRI .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2022

First Posted

July 18, 2022

Study Start

August 5, 2022

Primary Completion

April 3, 2023

Study Completion

April 3, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Only authorized personal listed on this IRB will have access to the data. During and after the study, all study records will be assigned a unique subject identifier code to protect the confidentiality of the participant's personal information. The information will be labeled with an unidentifiable code to reduce the risks to participant privacy. Once research information has been collected, we may share some of it. Any research information shared with people outside of Shirley Ryan AbilityLab/Northwestern University will not contain the participant's name, address, telephone or social security number, or any other direct personal identifier unless disclosure of the direct identifier is required by law.

Locations

US(1)