NCT00726050

Brief Summary

This study will use repetitive transcranial magnetic stimulation, or rTMS (magnetic stimulation to the brain), to examine how the brain distinguishes between two signals that are spaced very closely in time. The ability to tell the difference between sensory signals is important to understanding sensory input. Understanding how this works may help to develop new treatments for sensory deficits. Healthy volunteers 18 years of age and older may be eligible for this study. Participants undergo the following procedures during three visits to the NIH Clinical Center: rTMS - all visits (sham rTMS on one visit) : For TMS, a wire coil is held on the scalp. A brief electrical current passed through the coil creates a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. Theta burst stimulation (TBS) - all visits (sham TBS on one visit): Same as TMS, but brief pulses of electrical current are passed through the coil. Subjects undergo intermittent TBS on one visit and continuous TBS on another. Somatosensory evoked potential (SEP) - all visits: SEP tests how sensory information travels along the nerves to the spinal cord and brain. A small metal disk electrode placed on an arm delivers a small electrical shock. Electrodes placed on the scalp record how the impulse travels over the nerve pathways to the cerebral cortex of the brain. EEG (see below) records what sensory information the brain is detecting and processing. Paired-pulse SEP is done before and after TBS. Temporal discrimination threshold - all visits: This test investigates the brain's ability to discriminate sensory information. Electrodes are placed on the subject's wrist. Two electrical pulses are delivered to the nerve at the wrist at different spaced intervals to determine when the subject feels the two pulses are fused into one. This test is done before and after TBS. Electroencephalography (EEG) - all visits: This test records brain waves (electrical activity of the brain). Electrodes are placed on the scalp with an electrode cap. The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

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

July 28, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2010

Completed
Last Updated

July 2, 2017

Status Verified

April 29, 2010

First QC Date

July 30, 2008

Last Update Submit

June 30, 2017

Conditions

Keywords

Theta Burst StimulationSomatosensory StimulationSomatosensory CortexTactile DiscriminationHealthy VolunteerHV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Absence of dystonia or other neurological conditions

You may not qualify if:

  • Concurrent medical, surgical, neurologic or psychiatric condition
  • History of neurological disorders
  • History of seizure disorder
  • Pregnant women
  • Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye

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)

  • Aglioti SM, Fiorio M, Forster B, Tinazzi M. Temporal discrimination of cross-modal and unimodal stimuli in generalized dystonia. Neurology. 2003 Mar 11;60(5):782-5. doi: 10.1212/01.wnl.0000046528.24693.5b.

    PMID: 12629233BACKGROUND
  • Akatsuka K, Wasaka T, Nakata H, Inui K, Hoshiyama M, Kakigi R. Mismatch responses related to temporal discrimination of somatosensory stimulation. Clin Neurophysiol. 2005 Aug;116(8):1930-7. doi: 10.1016/j.clinph.2005.04.021.

    PMID: 15982927BACKGROUND
  • Angel A. Cortical responses to paired stimuli applied peripherally & at sites along the somato-sensory pathway. J Physiol. 1967 Jul;191(2):427-48. doi: 10.1113/jphysiol.1967.sp008260.

    PMID: 6050113BACKGROUND

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 30, 2008

First Posted

July 31, 2008

Study Start

July 28, 2008

Study Completion

April 29, 2010

Last Updated

July 2, 2017

Record last verified: 2010-04-29

Locations