NCT03434093

Brief Summary

Background: Research shows that the parietal and prefrontal areas of the brain are involved in short-term memory. Researchers want to look at the effects of transcranial magnetic stimulation (TMS) of these areas on short-term memory and brain activity. They will use functional magnetic resonance imaging (fMRI) to look at brain activity. Objective: To look at the effects of TMS on brain pathways involved in memory. Eligibility: Healthy, right-handed adults ages 18-50 Design: Participants will have 3 or 4 visits at least 1 week apart. They cannot drink alcohol for at least 48 hours before each visit. The screening visit lasts about 1 (Omega) hours. It can be combined with the first testing visit. Screening includes:

  • Medical history
  • Physical exam
  • Neurological exam
  • Urine tests
  • Questionnaires about being left or right handed and about their ability to imagine physical activities. The first testing visit lasts about 1 (Omega) hours and includes an MRI. For the MRI, participants lie on a table that slides into a machine. They will lie still or perform simple memory tasks on a computer screen. The second and third testing visits last about 3 hours. Participants will have:
  • 2 MRIs
  • TMS: A wire coil is held to the scalp. A brief electrical current passes through the coil to create a magnetic pulse that affects brain activity. They will perform simple memory tasks.
  • EMG: Small electrodes are taped to the skin to record muscle activity while they rest. After the study, participants will complete a questionnaire about any discomfort they experienced during the study. ...

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

February 3, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

22 days

First QC Date

February 14, 2018

Last Update Submit

February 27, 2019

Conditions

Keywords

Paired Associative Stimulation (PAS)Functional Magnetic Resonance Imaging (fMRI)Electrical Field ModelingWorking Memory

Outcome Measures

Primary Outcomes (1)

  • Resting state functional connectivity change induced by the paired associative stimulation

    Study completion

Secondary Outcomes (1)

  • Difference in the visual angle error of a working memory task between the DLPFC-PCC and PPC-DLPFC paired associative stimulation

    Study completion

Study Arms (2)

PPC-DLPFC

ACTIVE COMPARATOR

In this arm, the TMS paired-pulses will be first delivered over the posterior parietal cortex (PPC) and then over the dorsolateral prefrontal cortex (DLPFC)

Device: Transcranial Magnetic Stimulation (TMS)Behavioral: Working Memory Task

DLPFC-PPC

ACTIVE COMPARATOR

Arm Description: In this arm, the TMS paired-pulses will be first delivered over the over the dorsolateral prefrontal cortex (DLPFC) and then posterior parietal cortex (PPC)

Device: Transcranial Magnetic Stimulation (TMS)Behavioral: Working Memory Task

Interventions

Description: This will comprise single and repeated paired-pulses delivered over motor and non-motor areas.

DLPFC-PPCPPC-DLPFC

This will consist in remembering an item presented 1 to 5 steps before the inquiry. This task will span the whole duration of the functional MRI acquisition.

DLPFC-PPCPPC-DLPFC

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-50 years.
  • Right-handed (handedness questionnaire will be part of the initial evaluation)
  • Able to give informed consent.
  • Have a normal neurological exam within the last year and MoCA\>27
  • Willing and able to abstain from alcohol for at least 48 hours prior to the study.
  • Willing to not participate in other rTMS studies in the week preceding visits for the current protocol.

You may not qualify if:

  • has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if he/she was a welder or metal worker, since small metal fragments may be found in the eyes.
  • is uncomfortable in small closed spaces (claustrophobia) so that he/she would feel uncomfortable in the MRI machine.
  • is not able to lie comfortably on the back for up to 2 hours
  • has hearing loss.
  • is pregnant.
  • Self-reported consumption of \>14 alcoholic drinks/week for a man and \>7 alcoholic drinks/week for a woman.
  • History of or current brain tumor, stroke, head trauma with loss of consciousness, epilepsy or seizures.
  • Taking medications that act directly on the central nervous system such as anti-epileptics, anti-histamines, anti-parkinsonian medication, medication for insomnia, anti-depressants, anti-anxiety medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Casula EP, Pellicciari MC, Picazio S, Caltagirone C, Koch G. Spike-timing-dependent plasticity in the human dorso-lateral prefrontal cortex. Neuroimage. 2016 Dec;143:204-213. doi: 10.1016/j.neuroimage.2016.08.060. Epub 2016 Aug 31.

    PMID: 27591116BACKGROUND
  • Koch G, Ponzo V, Di Lorenzo F, Caltagirone C, Veniero D. Hebbian and anti-Hebbian spike-timing-dependent plasticity of human cortico-cortical connections. J Neurosci. 2013 Jun 5;33(23):9725-33. doi: 10.1523/JNEUROSCI.4988-12.2013.

    PMID: 23739969BACKGROUND
  • Ma WJ, Husain M, Bays PM. Changing concepts of working memory. Nat Neurosci. 2014 Mar;17(3):347-56. doi: 10.1038/nn.3655. Epub 2014 Feb 25.

    PMID: 24569831BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 15, 2018

Study Start

February 3, 2019

Primary Completion

February 25, 2019

Study Completion

February 25, 2019

Last Updated

February 28, 2019

Record last verified: 2019-02