NCT01006109

Brief Summary

Background: \- Most of the time, humans make decisions according to their consequences, especially if they will be beneficial, and will avoid or try to avoid doing an action if it has a bad outcome. The way that the brain prepares a movement has been studied in detail, but the way the brain makes decisions before carrying out an action is still poorly understood. Researchers are interested in learning more about the decision-making process and how it affects the brain. Objectives: \- To record the activity of the brain during decision-making processes. Eligibility: \- Healthy, right-handed volunteers between 18 and 40 years of age. Design:

  • Potential participants will have a screening visit with a medical history and neurological examination to determine eligibility.
  • This study requires seven visits: one magnetic resonance imaging (MRI) visit and 6 magnetoencephalography (MEG) recording visits. The MEG recording visits will include transcranial magnetic stimulation (TMS). All visits will be spaced at least 1 week apart. Total participation will last about 6 weeks.
  • Participants will have an MRI scan at the first study visit.
  • The MEG procedures will record brain activity during a series of computer tests involving winning or losing money. TMS will be performed during these visits, separate from the test....

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

October 22, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2017

Completed
Last Updated

December 17, 2019

Status Verified

September 7, 2017

First QC Date

October 30, 2009

Last Update Submit

December 14, 2019

Conditions

Keywords

MEGRepetitive TMS (rTMS)Decision-MakingHealthy VolunteersHVHealthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Performance of each subject, before and after each cTBS session. We will measure their reaction time and the number of errors which corresponds to the number of times the subject did not choose the target which could have made him/her win money...

    During the MEG recording

Secondary Outcomes (1)

  • MEG signal: latency and amplitude of evoked and induced activity related to decision-making, without and after cTBS. The cerebral sources of these activities will also be computed and their interaction will be studied using source coherence ana...

    During the MEG recording

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 to 40 years
  • Right-handed (Edinburgh Handedness Quotient greater than 60).

You may not qualify if:

  • Abnormal neurological exam, current or past history of neurological disease or psychiatric disease. Patients with neurological diseases of the central nervous system that impair the motor system or cognitive function will be excluded. Patients with axis I psychiatric disorders will be excluded. Such disorders will be identified or suspected on neurologic examination. If there is any uncertainty about a possible psychiatric diagnosis, psychiatric consultation will be obtained.
  • Use of antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson drugs or stimulants during the 3 months prior to their screening visit, and/or hypnotics or antihistamines during the 1 month prior to their screening visit
  • Having a pacemaker, an implanted medical pump, a metal plate or metal object in the skull or eye (for example, after brain surgery), or a history of seizure disorder
  • Pregnancy
  • Any contraindication to scanning on the NMR Center MRI safety screening questionnaire: cardiac pacemaker; implanted cardiac defibrillator; aneurysm clip; neuro or bone stimulator; insulin or infusion pump; implanted drug infusion device; cochlear, otologic, or ear implant; prostate radiation seeds; IUD (intrauterine device); transdermal medication patch (Nitro); any type of prosthesis (eye, penile); heart valve prosthesis; shunt (spinal/intraventricular); wire sutures or surgical staples; bone/joint pin, screw, nail, plate; body tattoos or makeup (eyeliner/lip); body piercing(s) (non-removable); breast tissue expander; any metallic implants or objects.
  • Metallic dental fillings that are likely to cause MRI artifacts
  • Claustrophobia
  • Inability to give informed consent
  • Personal or family history of hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Andrew C, Pfurtscheller G. Event-related coherence as a tool for studying dynamic interaction of brain regions. Electroencephalogr Clin Neurophysiol. 1996 Feb;98(2):144-8. doi: 10.1016/0013-4694(95)00228-6.

    PMID: 8598174BACKGROUND
  • Andrew C, Pfurtscheller G. Dependence of coherence measurements on EEG derivation type. Med Biol Eng Comput. 1996 May;34(3):232-8. doi: 10.1007/BF02520079.

    PMID: 8762831BACKGROUND
  • Brandt SA, Ploner CJ, Meyer BU, Leistner S, Villringer A. Effects of repetitive transcranial magnetic stimulation over dorsolateral prefrontal and posterior parietal cortex on memory-guided saccades. Exp Brain Res. 1998 Jan;118(2):197-204. doi: 10.1007/s002210050272.

    PMID: 9547088BACKGROUND

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

October 22, 2009

Study Completion

September 7, 2017

Last Updated

December 17, 2019

Record last verified: 2017-09-07

Locations