Healthy Clinical Trial
Official title:
Neural Correlates of Observation of Tactile Stimulation in Healthy Subjects
Verified date | September 2, 2008 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2, 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
- INCLUSION CRITERIA: Only healthy right-handed volunteers aged 18 to 75 years who fulfill the inclusion criteria will be included in this protocol. Subjects should be able to sustain attention to the task over 10 minutes. All volunteers should have no history of neurological and psychiatric illness. EXCLUSION CRITERIA: 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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