HealthyNCT00091533
Neural Correlates of Observation of Tactile Stimulation in Healthy Subjects
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Healthy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2004to 2 Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Objective:
There is growing evidence that a mirror system for action observation exists. Neurons in the monkey premotor cortex discharge with performance of goal directed actions and also with observation of another individual performing a similar action. This mirror neuron system for action observation seems to be important for the recognition and understanding of actions. Recently, bimodal neurons, sensitive both for tactile stimulation and for visual stimuli, were found in the parietal cortex. This suggests the idea that there might be a similar mirror neuron system for observing and receiving (or experiencing) tactile stimulation. The neuronal correlates of observing tactile stimulation are mainly unknown. The purpose of this protocol is to determine the pattern of brain activation related to the observation of a tactile stimulated hand.
Study Population:
We will test our hypothesis by means of a functional MRI (fMRI) experiment in a group of healthy subjects.
Design:
We hypothesize that observation of touch will rely on the activation of a cortical network that is different form the observation of non-touch and is in part overlapping with cortical structures active during real tactile stimulation (i.e., somatosensory cortex). Further, we hypothesize that the observation of touch enhances activation in the somatosensory cortex during real tactile stimulation.
Outcome Measures:
Our outcome measure will be an increase in the number of activated voxels in the somatosensory cortex during the touch observation (for both hypothesis). This would give an important hint for a mirror system for observed and received touch. A mirror neuron system for observed touch may become an important tool in rehabilitative treatment for patients with somatosensory impairments.
- Conditions
- Healthy
- Keywords
- fMRI, Mirror Neuron System, Bimodal Neurons, Somatosensory Cortex, Rehabilitation, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2004 (estimated)
- Study start3 Sep 2004
- Study completion2 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091533
- Sponsor's protocol ID
- 040278
- Other IDs
- 04-N-0278
- Status last verified
- 2 Sep 2008
- First submitted
- 9 Sep 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 11848707Desmond 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.
PubMed 12204303Fadiga 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.
PubMed 7666169
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Observation of Tactile Stimulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00091533
- Acronym / sponsor ID
- 040278
- Conditions
- Healthy
- Keywords
- fMRI, Mirror Neuron System, Bimodal Neurons, Somatosensory Cortex, Rehabilitation, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 3 Sep 2004
- Study completion
- 2 Sep 2008
- First posted
- 10 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective:
There is growing evidence that a mirror system for action observation exists. Neurons in the monkey premotor cortex discharge with performance of goal directed actions and also with observation of another individual performing a similar action. This mirror neuron system for action observation seems to be important for the recognition and understanding of actions. Recently, bimodal neurons, sensitive both for tactile stimulation and for visual stimuli, were found in the parietal cortex. This suggests the idea that there might be a similar mirror neuron system for observing and receiving (or experiencing) tactile stimulation. The neuronal correlates of observing tactile stimulation are mainly unknown. The purpose of this protocol is to determine the pattern of brain activation related to the observation of a tactile stimulated hand.
Study Population:
We will test our hypothesis by means of a functional MRI (fMRI) experiment in a group of healthy subjects.
Design:
We hypothesize that observation of touch will rely on the activation of a cortical network that is different form the observation of non-touch and is in part overlapping with cortical structures active during real tactile stimulation (i.e., somatosensory cortex). Further, we hypothesize that the observation of touch enhances activation in the somatosensory cortex during real tactile stimulation.
Outcome Measures:
Our outcome measure will be an increase in the number of activated voxels in the somatosensory cortex during the touch observation (for both hypothesis). This would give an important hint for a mirror system for observed and received touch. A mirror neuron system for observed touch may become an important tool in rehabilitative treatment for patients with somatosensory impairments.
Study design
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11848707Avikainen 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.
- Background: PubMed 12204303Desmond 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.
- Background: PubMed 7666169Fadiga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091533, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.