Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Modulation of the Parieto-frontal Communication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434093
Recruitment Status : Withdrawn (Investigator left NIH)
First Posted : February 15, 2018
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE February 15, 2018
Last Update Posted Date February 28, 2019
Actual Study Start Date  ICMJE February 3, 2019
Actual Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
Resting state functional connectivity change induced by the paired associative stimulation [ Time Frame: Study completion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
Difference in the visual angle error of a working memory task between the DLPFC-PCC and PPC-DLPFC paired associative stimulation [ Time Frame: Study completion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modulation of the Parieto-frontal Communication
Official Title  ICMJE Modulation of the Parieto-frontal Communication
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.

...

Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Normal Physiology
Intervention  ICMJE
  • Device: Transcranial Magnetic Stimulation (TMS)
    Description: This will comprise single and repeated paired-pulses delivered over motor and non-motor areas.
  • Behavioral: Working Memory Task
    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.
Study Arms  ICMJE
  • Active Comparator: PPC-DLPFC
    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)
    Interventions:
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Behavioral: Working Memory Task
  • Active Comparator: DLPFC-PPC
    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)
    Interventions:
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Behavioral: Working Memory Task
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 27, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2018)
26
Actual Study Completion Date  ICMJE February 25, 2019
Actual Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT03434093
Other Study ID Numbers  ICMJE 180054
18-N-0054
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Study Sponsor  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP