NCT00091533

Brief Summary

This study will examine activity in the brain during the observation of touch. Studies with animals have shown that mirror neurons, or nerve cells, are active during the observation and performance of an action. The researchers for this study hypothesize that a similar system pertains to observing and experiencing touch. Patients ages 18 to 75 years old who are in good health, are right handed, and who are able to perform simple tasks that require attention may be eligible for this study. Pregnant women are not eligible. Patients who have not had a health screening at NIH will undergo a clinical and neurological exam. Women of childbearing potential will also have a pregnancy test. The screening will take about 2 to 3 hours. A diagnostic magnetic resonance imaging (MRI) scan will be performed if patients have not undergone one in the previous 12 months. During the procedure, patients will lie still on a table that will slide into the enclosed tunnel of the scanner. They will be asked to lie as still as possible for up to a few minutes at a time. As the scanner takes pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to reduce the noise. Patients will be able to communicate with the MRI staff at all times during the scan, and they may ask to be moved out of the machine at any time. This scan will take about 2 hours. Two sessions are involved in the study. The first one is intended to familiarize patients with the procedure. During it, they will learn about hand stimulus, through watching a video showing the index finger of a hand being touched by a stick repeatedly. Then the activity will be repeated, but this time, a researcher will also touch the patient's index finger while he or she is watching the video. This session will take about 1 hour. The second session consists of a functional MRI scan, or fMRI. During it, pictures of the brain will be taken while patients perform tasks. All tasks will be explained in advance, and patients will have an opportunity to practice them before entering the scanner. The fMRI scan will take 1 to 2 hours. The researchers will discuss the results of the tests with the participants. There is not a direct benefit to those who take part in the study. However, it is hoped that resulting information will enhance researchers' understanding about how the brain processes observed information.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2004

Longer than P75 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

September 3, 2004

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2004

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2008

Completed
Last Updated

July 2, 2017

Status Verified

September 2, 2008

First QC Date

September 9, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

fMRIMirror Neuron SystemBimodal NeuronsSomatosensory CortexRehabilitationHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects should be able to sustain attention to the task over 10 minutes.
  • All volunteers should have no history of neurological and psychiatric illness.

You may not qualify if:

  • Volunteers with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
  • Volunteers with 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).
  • Volunteers with increased intracranial pressure (as evaluated by clinical examination).
  • Volunteers with unstable cardiac arrhythmia.
  • Volunteers with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.
  • Volunteers with more than moderate to severe microangiopathy (as assessed by multiple peri-ventricular T2 hyperintensity on the pre-experimental anatomical MRI), polyneuropathy (as assessed by clinical examination), diabetes mellitus (medical record), or ischemic peripheral disease (as assessed by clinical examination).
  • Volunteers who are on medication with the potential to influence nervous system function, who have a history of surgery with metallic implants or a known history of metallic particles in the eye, a cardiac pacemaker, intracardiac lines, neural stimulators, cochlear implants.
  • Volunteers who are pregnant.
  • Volunteers with significant visual loss/deficits.
  • Volunteers with MRI contraindications.
  • Volunteers with impaired sensation or neuropathy of the hand.

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)

  • Avikainen S, Forss N, Hari R. Modulated activation of the human SI and SII cortices during observation of hand actions. Neuroimage. 2002 Mar;15(3):640-6. doi: 10.1006/nimg.2001.1029.

    PMID: 11848707BACKGROUND
  • Desmond JE, Glover GH. Estimating sample size in functional MRI (fMRI) neuroimaging studies: statistical power analyses. J Neurosci Methods. 2002 Aug 30;118(2):115-28. doi: 10.1016/s0165-0270(02)00121-8.

    PMID: 12204303BACKGROUND
  • Fadiga L, Fogassi L, Pavesi G, Rizzolatti G. Motor facilitation during action observation: a magnetic stimulation study. J Neurophysiol. 1995 Jun;73(6):2608-11. doi: 10.1152/jn.1995.73.6.2608.

    PMID: 7666169BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 9, 2004

First Posted

September 10, 2004

Study Start

September 3, 2004

Study Completion

September 2, 2008

Last Updated

July 2, 2017

Record last verified: 2008-09-02

Locations