NCT00396890

Brief Summary

This study will determine whether stimulation of the right side of the brain with repetitive transcranial magnetic stimulation (rTMS) followed by stimulation of the left side with theta burst stimulation (TBS) can temporarily change brain activity and improve hand movements in subjects more than has recently been achieved with rTMS alone. For rTMS, a wire coil is held on the patient's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. The subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms or legs. This study uses two kinds of rTMS. In one (Hz rTMS), magnetic pulses are given once per second for a period of 20 minutes; in the other (TBS), a series of pulses are given in bursts, each lasting 2 seconds, for a period of 3 minutes. Healthy normal volunteers between 18 and 55 years of age may be eligible for this study. Participants undergo the following procedures during three visits to the NIH Clinical Center: Visit 1: Participants receive either real or sham rTMS applied on the right side of the brain followed by real or sham TBS applied on the left side of the brain. In addition, subjects undergo the following: " Pinch force: Subjects press a wedged instrument between the thumb and index finger as hard as they can during several trials every 10 seconds. " Speed tapping: Subjects press a key on a computer keyboard as quickly as possible for 10 seconds, repeated for several trials. " Simple reaction time: Subjects respond as quickly as possible to a "go" signal presented on a computer monitor by performing a quick wrist movement. " Electromyography: Subjects' muscle activity is recorded using electrodes (small metal disks) filled with conductive gel and taped to the skin over the muscle. Visits 2 and 3 Visit 2 is scheduled for one day after visit 1, and visit 3 is one week after visit 1. Participants do not have brain stimulation during these two visits, but they have TMS measurements, behavioral measurements, and electromyography (EMG) to see if the brain stimulation done during the first visit is still present after a period of time. At all three visits, participants comp...

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

Typical duration for all trials

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

November 3, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2008

Completed
Last Updated

July 2, 2017

Status Verified

December 15, 2008

First QC Date

November 7, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Theta Burst StimulationRepetitive TMS (rTMS)Transcranial Magnetic Stimulation (TMS)Primary Motor CortexInterhemispheric DisinhibitionHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-55 years
  • Able to perform tasks required by the study
  • Willing and able to give consent

You may not qualify if:

  • Subjects are not eligible for this experiment if they:
  • Are unable to perform the tasks
  • Have history of severe alcohol or drug abuse, psychiatric illness
  • Have problems with movement of the hands
  • Are currently under medication with central acting drugs
  • Are left-handed
  • Have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy, or diabetes mellitus
  • Have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, and metal in the cranium, with the exception of dental braces
  • Are pregnant

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)

  • Boroojerdi B, Battaglia F, Muellbacher W, Cohen LG. Mechanisms influencing stimulus-response properties of the human corticospinal system. Clin Neurophysiol. 2001 May;112(5):931-7. doi: 10.1016/s1388-2457(01)00523-5.

    PMID: 11336911BACKGROUND
  • Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398.

    PMID: 9153480BACKGROUND
  • Di Lazzaro V, Oliviero A, Mazzone P, Pilato F, Saturno E, Dileone M, Insola A, Tonali PA, Rothwell JC. Short-term reduction of intracortical inhibition in the human motor cortex induced by repetitive transcranial magnetic stimulation. Exp Brain Res. 2002 Nov;147(1):108-13. doi: 10.1007/s00221-002-1223-5. Epub 2002 Sep 18.

    PMID: 12373375BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 8, 2006

Study Start

November 3, 2006

Study Completion

December 15, 2008

Last Updated

July 2, 2017

Record last verified: 2008-12-15

Locations