Study Stopped
Investigator left NIH
Modulation of the Parieto-frontal Communication
2 other identifiers
interventional
N/A
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2019
Shorter than P25 for not_applicable
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
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedStudy Start
First participant enrolled
February 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2019
CompletedFebruary 28, 2019
February 1, 2019
22 days
February 14, 2018
February 27, 2019
Conditions
Keywords
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 COMPARATORIn this arm, the TMS paired-pulses will be first delivered over the posterior parietal cortex (PPC) and then over the dorsolateral prefrontal cortex (DLPFC)
DLPFC-PPC
ACTIVE COMPARATORArm 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)
Interventions
Description: This will comprise single and repeated paired-pulses delivered over motor and non-motor areas.
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.
Eligibility Criteria
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: 27591116BACKGROUNDKoch 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: 23739969BACKGROUNDMa 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
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Hallett, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
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