HealthyNCT00080067
Rhythm Perception and Generation
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 how different brain areas are involved in the perception of rhythmic patterns and the performance of rhythmic movements. Patients with certain types of brain diseases, such as Parkinson's disease and some types of stroke, may have difficulty performing rhythmic movements, such as finger… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2004to 23 Feb 2009
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fifty healthy, right-handed adult (aged between 21 to 65 years old) volunteers will be recruited from people who are registered as HMCS normal volunteers. All subjects participating in MR studies should have a valid Clinical Center Medical Record Number.
- Female subjects of childbearing potential will have a pregnancy test and a specific interview prior to the study to ensure that pregnant subjects will not participate in the study.
Who cannot join
- Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI.
- Pregnant female. A pregnancy test will be performed within 24 hours preceding each MRI and if the result is positive, that subject will not be studied.
- Subjects with claustrophobia
- Subjects with any visual, motor or hearing difficulties
- Musicians
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
Official title: fMRI Study on Mechanism of Rhythm Perception and Generation
This study will examine how different brain areas are involved in the perception of rhythmic patterns and the performance of rhythmic movements. Patients with certain types of brain diseases, such as Parkinson's disease and some types of stroke, may have difficulty performing rhythmic movements, such as finger tapping.
Healthy, right-handed volunteers between 21 and 65 years of age may be eligible for this study. Candidates with visual, motor or hearing problems are excluded, as are musicians and pregnant women.
Read more
Participants will come to the National Institutes of Health (NIH) Clinical Center for up to six sessions of functional magnetic resonance imaging (fMRI) scanning. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The scanner is a metal cylinder surrounded by a magnetic field. During the MRI, the subject lies still for up to 20 minutes at a time on a table in the cylinder and wears earplugs to muffle loud knocking noises that occur with the electrical switching of the magnetic fields. He or she can communicate with the MRI staff through a microphone at all times during the procedure.
For fMRI, images are obtained while the subject performs a task, such as hearing sounds or moving a finger. The machine detects changes in brain movement that are involved in performing the task. The tasks are explained, and subjects can practice them before entering the scanner.
Read the detailed description
Objective
Rhythmic movements, such as finger tapping, are relatively simple. However, many brain areas including motor, somatosensory, premotor and prefrontal cortex, supplementary motor area, basal ganglia, cerebellum, etc. have been reported to be activated during rhythmic movements. Patients with lesions located in the extrapyramidal or cerebellar system, such as patients with Parkinson's disease, cerebellar ataxia or stroke with a lesion in these systems, have difficulties in performing rhythmic movements. Timing deficits after basal ganglia or cerebellar damage could also be due to abnormalities in interconnecting cortical systems commonly associated with these processes. Few studies have examined involvement of cerebral cortex in time perception.
The purpose of this study is to detect the brain areas associated with three hypothesized processes associated with rhythm perception and generation: (1) perception of external rhythmic stimulation, (2) internal rhythm generation and (3) execution of rhythmic movement. To investigate whether the process of rhythm perception is common across sensory modalities, we will use auditory and visual stimulation.
Study population
This research will be conducted using normal adult volunteers.
Design
Using functional magnetic resonance imaging, we will examine the brain activity of subjects while they will hear or watch rhythmic stimulation and press buttons rhythmically with their fingers. A series of experiments will be designed to demonstrate the hypothesized three processes separately.
Outcome measures
The brain activity correlated with experimental conditions and behavioral data (the timing error of button press to the corresponding rhythmic stimulation) will be collected and analyzed by using statistical parametric mapping (SPM).
The findings we expect to obtain with this experiment will contribute to basic knowledge for better understanding of the pathophysiology of the disturbance of perception and generation of rhythm in patients with neurological disorders, and give theoretical background for repetitive, rhythmically patterned movement training in neurorehabilitation.
- Conditions
- Healthy
- Keywords
- Movement, Anticipation, Stimulation, Timing, Execution, Perception, Rhythm, 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 posted23 Mar 2004 (estimated)
- Study start22 Mar 2004
- Study completion23 Feb 2009
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
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080067
- Sponsor's protocol ID
- 040146
- Other IDs
- 04-N-0146
- Status last verified
- 23 Feb 2009
- First submitted
- 23 Mar 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Artieda J, Pastor MA, Lacruz F, Obeso JA. Temporal discrimination is abnormal in Parkinson's disease. Brain. 1992 Feb;115 Pt 1:199-210. doi: 10.1093/brain/115.1.199.
PubMed 1559154Aschersleben G. Temporal control of movements in sensorimotor synchronization. Brain Cogn. 2002 Feb;48(1):66-79. doi: 10.1006/brcg.2001.1304.
PubMed 11812033Asanuma H, Keller A. Neuronal mechanisms of motor learning in mammals. Neuroreport. 1991 May;2(5):217-24. doi: 10.1097/00001756-199105000-00001.
PubMed 1912451
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
- fMRI Study on Mechanism of Rhythm Perception and Generation
- ClinicalTrials.gov ID
- NCT00080067
- Acronym / sponsor ID
- 040146
- Conditions
- Healthy
- Keywords
- Movement, Anticipation, Stimulation, Timing, Execution, Perception, Rhythm, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 22 Mar 2004
- Study completion
- 23 Feb 2009
- First posted
- 23 Mar 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 how different brain areas are involved in the perception of rhythmic patterns and the performance of rhythmic movements. Patients with certain types of brain diseases, such as Parkinson's disease and some types of stroke, may have difficulty performing rhythmic movements, such as finger tapping.
Healthy, right-handed volunteers between 21 and 65 years of age may be eligible for this study. Candidates with visual, motor or hearing problems are excluded, as are musicians and pregnant women.
Participants will come to the National Institutes of Health (NIH) Clinical Center for up to six sessions of functional magnetic resonance imaging (fMRI) scanning. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The scanner is a metal cylinder surrounded by a magnetic field. During the MRI, the subject lies still for up to 20 minutes at a time on a table in the cylinder and wears earplugs to muffle loud knocking noises that occur with the electrical switching of the magnetic fields. He or she can communicate with the MRI staff through a microphone at all times during the procedure.
For fMRI, images are obtained while the subject performs a task, such as hearing sounds or moving a finger. The machine detects changes in brain movement that are involved in performing the task. The tasks are explained, and subjects can practice them before entering the scanner.
Detailed description
Objective
Rhythmic movements, such as finger tapping, are relatively simple. However, many brain areas including motor, somatosensory, premotor and prefrontal cortex, supplementary motor area, basal ganglia, cerebellum, etc. have been reported to be activated during rhythmic movements. Patients with lesions located in the extrapyramidal or cerebellar system, such as patients with Parkinson's disease, cerebellar ataxia or stroke with a lesion in these systems, have difficulties in performing rhythmic movements. Timing deficits after basal ganglia or cerebellar damage could also be due to abnormalities in interconnecting cortical systems commonly associated with these processes. Few studies have examined involvement of cerebral cortex in time perception.
The purpose of this study is to detect the brain areas associated with three hypothesized processes associated with rhythm perception and generation: (1) perception of external rhythmic stimulation, (2) internal rhythm generation and (3) execution of rhythmic movement. To investigate whether the process of rhythm perception is common across sensory modalities, we will use auditory and visual stimulation.
Study population
This research will be conducted using normal adult volunteers.
Design
Using functional magnetic resonance imaging, we will examine the brain activity of subjects while they will hear or watch rhythmic stimulation and press buttons rhythmically with their fingers. A series of experiments will be designed to demonstrate the hypothesized three processes separately.
Outcome measures
The brain activity correlated with experimental conditions and behavioral data (the timing error of button press to the corresponding rhythmic stimulation) will be collected and analyzed by using statistical parametric mapping (SPM).
The findings we expect to obtain with this experiment will contribute to basic knowledge for better understanding of the pathophysiology of the disturbance of perception and generation of rhythm in patients with neurological disorders, and give theoretical background for repetitive, rhythmically patterned movement training in neurorehabilitation.
Study design
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fifty healthy, right-handed adult (aged between 21 to 65 years old) volunteers will be recruited from people who are registered as HMCS normal volunteers. All subjects participating in MR studies should have a valid Clinical Center Medical Record Number.
- Female subjects of childbearing potential will have a pregnancy test and a specific interview prior to the study to ensure that pregnant subjects will not participate in the study.
Key exclusion criteria (5 listed)
- Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI.
- Pregnant female. A pregnancy test will be performed within 24 hours preceding each MRI and if the result is positive, that subject will not be studied.
- Subjects with claustrophobia
- Subjects with any visual, motor or hearing difficulties
- Musicians
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 1559154Artieda J, Pastor MA, Lacruz F, Obeso JA. Temporal discrimination is abnormal in Parkinson's disease. Brain. 1992 Feb;115 Pt 1:199-210. doi: 10.1093/brain/115.1.199.
- Background: PubMed 11812033Aschersleben G. Temporal control of movements in sensorimotor synchronization. Brain Cogn. 2002 Feb;48(1):66-79. doi: 10.1006/brcg.2001.1304.
- Background: PubMed 1912451Asanuma H, Keller A. Neuronal mechanisms of motor learning in mammals. Neuroreport. 1991 May;2(5):217-24. doi: 10.1097/00001756-199105000-00001.
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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 2 inclusion and 5 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 NCT00080067, 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.