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Central Nervous SystemNCT01006109

Recording and Modulation of Neuronal Mechanisms During Operant Conditioning: a MEG Study

An observational study of Central Nervous System, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Central Nervous System
How many people
20 participants
Where
1 siteUnited States
Study dates
22 Oct 2009to 7 Sep 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Claustrophobia
  • Inability to give informed consent
  • Personal or family history of hearing loss

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Recording and Modulation of Neuronal Mechanisms During Operant Conditioning: A MEG Study

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.
Read more

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....
Read the detailed description

Objective:

The objective is to study cerebral activity associated with reward-related decision making. We plan to analyze and localize electrical activity of the brain related to such processes with magnetoencephalography (MEG). We also want to modulate the activity of these areas using repetitive transcranial magnetic stimulation (rTMS). We would like to analyze the consequences of these procedures on both brain activity and behavioral performance. This protocol will provide new information on cortical regions involved in decision-making and how these areas communicate with one another.

Study population:

50 right-handed adult healthy volunteers.

Design:

A probabilistic reversal task will be performed: subjects will have to choose between pairs of stimuli associated with changing probabilities of rewards and losses. Using MEG, their cerebral activity will be recorded during task performance.

Since we want to modulate the cortical activity of cerebral areas involved in reward-related decision making, the study will be carried out in 8 different visits (screening visit, structural MRI acquisition and 6 recordings visits). In one visit, decision-making will be studied with no previous cortical stimulation. In 3 visits, decision-making will be studied after stimulation of one of 3 regions of interest. In one visit, decision-making will be studied after stimulation of a cortical area that is not thought to be involved in the process. Lastly, decision-making will be analyzed following a sham stimulation to test a possible placebo effect of rTMS.

Outcome measures:

Outcome measures are as follow:

  1. Task-related: reaction time and error rate during the task performance.
  2. MEG signal: scalp and source coherence between cortical regions, amplitude and latency of event-related potentials and even-related (de)synchronization.
Keywords
MEG, Repetitive TMS (rTMS), Decision-Making, Healthy Volunteers, HV, Healthy Volunteer

What is being measured

The primary outcome is the main question the study is designed to answer.

  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...

    Measured: During the MEG recording

Secondary outcomes (1)

  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...

    Measured: During the MEG recording

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2009 (estimated)
  2. Study start22 Oct 2009
  3. Study completion7 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01006109
Sponsor's protocol ID
100003
Other IDs
10-N-0003
Status last verified
7 Sep 2017
First submitted
30 Oct 2009
Last updated
17 Dec 2019
Results posted
No

Publications

  • 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.

    PubMed 8598174

  • 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.

    PubMed 8762831

  • 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.

    PubMed 9547088

Questions about this trial

What is this clinical trial studying?

An observational study of Central Nervous System, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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... (time frame: During the MEG recording). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01006109, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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