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Modulation of the Parieto-frontal Communication

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Withdrawn

Conditions

Normal Physiology

Treatments

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

Study type

Interventional

Funder types

NIH

Identifiers

NCT03434093
180054
18-N-0054

Details and patient eligibility

About

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.

...

Full description

Objective: This study aims to identify whether repetitive dual-site transcranial magnetic stimulation (TMS) can modulate the functional connectivity between the parietal and dorso-lateral prefrontal cortices.

Study population: The study involves 26 healthy volunteers.

Design: This controlled study comprises 3 main visits for each subject: (1) a baseline, evaluation visit during which fMRI will be acquired during a visual short memory task along with diffusion tensor imaging and structural MRI; (2) a visit during which resting state fMRI (rsfMRI) will be acquired, followed by paired-associative stimulation (PAS) with pulses delivered over the parietal and then over the dorso-lateral prefrontal cortex, in order to induce a temporary plastic change in the interaction between the parietal and prefrontal cortices; the PAS will be followed by another rsfMRI and task fMRI; (3) a visit identical to #2 during which the PAS will be delivered with pulses in reverse order of previous visit.

Outcome measures: The effects of PAS will be quantified with rsfMRI and a short working memory task, considered as a proxy for complex motor and cognitive control.

  • The primary outcome will be to investigate the resting state functional connectivity changes induced by each PAS intervention
  • The secondary outcome #1 will be to evaluate the difference in visual angle error between sessions 2 and 3 in a working memory task during which the subjects will be asked to remember the position of a bar presented on the screen at different time intervals before the inquiry.
  • The secondary outcome #2 will be to build an fMRI-DTI analysis pipeline for generation of TMS targets individually customized for each subject and a given task.

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

  • INCLUSION CRITERIA:
  • 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.

EXCLUSION CRITERIA:

-All participants must be able to undergo MRI and TMS, for which the MRI- and TMS-safety checklists will be part of the initial evaluation, and reconfirmed at the beginning of every visit. It will constitute as exclusion criteria if the participant:

  • 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

0 participants in 2 patient groups

PPC-DLPFC
Active Comparator group
Description:
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)
Treatment:
Behavioral: Working Memory Task
Device: Transcranial Magnetic Stimulation (TMS)
DLPFC-PPC
Active Comparator group
Description:
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)
Treatment:
Behavioral: Working Memory Task
Device: Transcranial Magnetic Stimulation (TMS)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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