Effects of Transcranial Magnetic Stimulation on Object Recognition

June 30, 2017 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

Modulating Behavior in Humans by Entrainment With Rhythmic Transcranial Magnetic Stimulation

Background:

- The brain has natural rhythms called brain waves. An electroencephalogram (EEG) can record these rhythms. When people identify the picture of a familiar object shown on a computer screen, the communication between certain regions of the brain increases. An EEG can detect these communication brain waves. Transcranial magnetic stimulation (TMS) can affect these brain waves by slightly changing the brain s rhythms. Researchers want to see if changing brain rhythms with TMS interferes with the ability to identify pictures of familiar objects. This study will provide more information about how TMS can affect brain waves and behavior.

Objectives:

- To see if TMS can interfere with the brain s ability to identify pictures of familiar objects.

Eligibility:

- Healthy volunteers between 18 and 70 years of age.

Design:

  • This study requires two visits to the clinical center. The first visit will last about 2 hours. The second visit will last about 4 hours.
  • Participants will be screened with a physical exam and medical history.
  • At the first visit, participants will have an object recognition test. Participants will look at pictures of several objects on a computer screen. They will then have to state whether the objects they see on the screen are familiar. The object recognition test will be done along with TMS.
  • At the second visit, participants will have an EEG while taking the object recognition test. Brain waves will be monitored during the test. They will then repeat the test while having repetitive TMS to study its effect on object recognition. The participants will then take the object recognition test alone for a final time. This will make sure that TMS effects (if any) on the ability to identify familiar object images are no longer present.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inter-hemispheric coherence (IHC) is one of the electroencephalography (EEG) parameters that measures synchronization of oscillations originating from brain regions of different hemispheres and thereby the functional connectivity between them. We know that object discrimination is associated with transient increase in IHC. In this study we will interfere with the transient IHC that is associated with midline object discrimination by using rhythmic repetitive transcranial magnetic stimulation (rTMS).

We will study the effects of entrainment by unilateral or bilateral, synchronous or asynchronous TMS pulses on behavior. The goal of the study is to determine if entrainment by TMS will affect task performance. If the results show that TMS by entrainment influenced behavior, then we can expect TMS to be a useful technique to explore the behavioral impact of specific neuronal oscillations under physiological as well as pathological conditions. Further, TMS could also find applications in rehabilitation or treatment of behavioral symptoms in patients with neuropsychiatric diseases.

STUDY POPULATION:

We intend to study 11 adult healthy volunteers on an outpatient basis.

STUDY DESIGN:

All the subjects will first participate in a screening session where the threshold TMS intensity for blocking object discrimination and the optimal coil orientation will be determined using single pulse TMS. Later they will attend the main experiment session where they will be asked to perform the object discrimination task in four blocks, of which the second, third and fourth will be in random order. During the first block, the individual coherence frequency will be determined by recording EEG during the task. During the second, third and fourth blocks, the subjects will receive either unilateral, bilateral or sham rTMS in a random order while EEG is being recorded. Short trains of 7 TMS pulses will be delivered during each trial. TMS pulses will be administered over left and/or right LOG at 80% of threshold intensity blocking object discrimination or 60% maximum stimulator output whichever is smaller.

OUTCOME MEASURES:

We expect that short trains of TMS will affect IHC depending on whether the pulses are synchronous or asynchronous. By modulating IHC, we expect changes in object discrimination task performance. The primary outcome measure in this study includes object discrimination task performance. During the study, we will also compute the individual frequency at which maximum coherence occurs, the threshold intensity and optimal coil direction for blocking object discrimination and the spatio-temporal characteristics of EEG waves during the rTMS trains to confirm that entrainment is occurring.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • Age between 18 - 70 years.
  • Able to give his/her own consent to participate in the study.

EXCLUSION CRITERIA:

  • Presence of cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye.
  • Pregnancy or lactation.
  • History of any serious medical illness or hearing problems
  • Intake of medication that affect the central nervous system like anti depressants, antihistamines, antipsychotics, dopamine agonists, benzodiazepines and antiepileptics in the past 3 months.
  • Presence of neurological or psychiatric illnesses like brain tumor, migraine, depression, bipolar disorder, schizophrenia.
  • History of any seizure.
  • Use or abuse of any drug in the past 6 months or intake of more than 7 alcoholic drinks a week in females and more than 14 alcoholic drinks a week in males.

Exclusion criteria specific for MRI::

  • Presence of metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye as these make having an MRI unsafe.
  • Presence of metallic dental fillings which are likely to cause MRI artifacts
  • Uncomfortable being in a small space for up to 2 hours.
  • Unable to lie flat on the back for up to 2 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of correct responses in the midline object recognition task.
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Threshold intensity for blocking object recognition
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 16, 2012

Primary Completion (Actual)

January 26, 2017

Study Completion (Actual)

January 26, 2017

Study Registration Dates

First Submitted

December 8, 2012

First Submitted That Met QC Criteria

December 8, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

January 26, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 130035
  • 13-N-0035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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