Recording and Modulation of Neuronal Mechanisms During Op... | NCT01006109

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

NCT01006109

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Status

Terminated

Last Update Posted

Dec 17, 2019Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Central Nervous System

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
10-N-0003

Status Module

Record Verification Date

Sep 7, 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2009

Primary Completion Date

Not provided

Completion Date

Sep 7, 2017

First Submitted Date

Oct 30, 2009

First Submission Date that Met QC Criteria

Oct 30, 2009

First Posted Date

Nov 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2019

Last Update Posted Date

Dec 17, 2019Actual

Description Module

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....

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:

Task-related: reaction time and error rate during the task performance.
MEG signal: scalp and source coherence between cortical regions, amplitude and latency of event-related potentials and even-related (de)synchronization.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:
1. Aged 18 to 40 years
2. Right-handed (Edinburgh Handedness Quotient greater than 60).

EXCLUSION CRITERIA:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mark Hallett, M.D.	National Institute of Neurological Disorders and Stroke (NINDS)	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8598174	Background	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.
8762831	Background	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.