NCT00413842

Brief Summary

This study will evaluate whether applying electrical stimulation on the cerebellum (posterior and lower part of the brain) can influence brain excitability and hand movement performance. A new technique became available to stimulate the brain: transcranial direct current stimulation (tDCS), which could improve the ability to learn. Researchers do not know whether applying tDCS over the cerebellum could also influence motor function, and they want to examine changes in brain excitability, by using transcranial magnetic stimulation (TMS). Patients ages 18 to 40 who are not pregnant may be eligible for this study. They will come to NIH for a medical history and completing a questionnaire about memory and attention. There will be five experiments, each up to 5 hours, for about 1 to 5 weeks, in which patients perform tasks like pinching a special device between the thumb and index fingers, or reaching for target objects on the computer screen. Patients will receive mild electrical stimulation over a different part of the head each day. Some experiments are done without the electrical current, but patients will not know which ones are with or without stimulation. There are also short questionnaires about attention, fatigue, and mood, to be completed before, during, and after each experiment. Patients will be connected to an electromyography (EMG) machine, to measure electrical activity of muscles. Electrodes are taped to the skin over one small hand muscle. TMS allows electrical pulses to pass through the brain to stimulate it. TMS is used at the beginning of each experiment to determine the precise location on the scalp of two target areas: cerebellum and motor cortex. TMS is a safe procedure. Discomfort, headache, or nausea can occur, but all symptoms usually go away promptly. During motor learning under tDCS, also a safe procedure, patients sit in a comfortable chair, and the arm and wrist and arm are kept still. Sponge electrodes are applied on the chin, back of the head, neck, collarbone, lateral part of the head, or above the eyebrow. A small electrical current is passed between electrodes. Patients may feel an itching or tingling sensation under the electrodes or see slight light flashes. tDCS is applied for 20 to 30 minutes. A magnetic resonance imaging (MRI) scan, which may also be involved, uses a strong magnetic field and radio waves to obtain images of body organs and tissues. Patients lie on a table in a cylinder and may be asked to lie still for up to 60 minutes at a time. This study will not have a direct benefit for participants. However, knowledge gained may help researchers identify ways to improve movement in people with a brain injury, such as chronic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2006

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

December 14, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2008

Completed
Last Updated

July 2, 2017

Status Verified

August 20, 2008

First QC Date

December 19, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Transcranial Direct Current Stimulation (tDCS)PlasticityPrimary Motor CortexCerebellumTranscranial Magnetic Stimulation (TMS)Healthy VolunteerHV

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18-40 years
  • able to perform tasks required by the study
  • willing and able to give consent

You may not qualify if:

  • unable to perform the tasks required by the study
  • history of severe alcohol or drug abuse, psychiatric illness like severe depression, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score \[MMSE\] of 23 or less), or degenerative brain processes such as Alzheimer's disease
  • severe uncontrolled medical problems (e.g., cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others), more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease
  • problems with movement of the hands
  • receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants (for the TMS component only)
  • pregnant (for the MRI component only)
  • medical or technical contraindications to MRI procedures or devices producing artifacts that impair MRI signal (e.g., pacemakers, implanted medication pumps, cochlear devices, neural stimulators, metal in the cranium, surgical clips, and other metal/magnetic implants, claustrophobia)

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)

  • Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.

    PMID: 15999258BACKGROUND
  • Antal A, Nitsche MA, Kincses TZ, Kruse W, Hoffmann KP, Paulus W. Facilitation of visuo-motor learning by transcranial direct current stimulation of the motor and extrastriate visual areas in humans. Eur J Neurosci. 2004 May;19(10):2888-92. doi: 10.1111/j.1460-9568.2004.03367.x.

    PMID: 15147322BACKGROUND
  • Khedr EM, Ahmed MA, Fathy N, Rothwell JC. Therapeutic trial of repetitive transcranial magnetic stimulation after acute ischemic stroke. Neurology. 2005 Aug 9;65(3):466-8. doi: 10.1212/01.wnl.0000173067.84247.36.

    PMID: 16087918BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 20, 2006

Study Start

December 14, 2006

Study Completion

August 20, 2008

Last Updated

July 2, 2017

Record last verified: 2008-08-20

Locations