Modulation of the Parieto-frontal Communication



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:2/28/2019
Start Date:March 1, 2019
End Date:December 31, 2019
Contact:Elaine P Considine, R.N.
Email:considinee@ninds.nih.gov
Phone:(301) 435-8518

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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.

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.

- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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mi
from
Bethesda, MD
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