HealthyNCT00055289
Brain Use of Sensory Information to Generate Movement
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 use transcranial magnetic stimulation (TMS) to investigate functions of brain regions that may use information from sensory organs, such as the eyes or ears, to generate movements. For TMS, a wire coil is held over the scalp. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Jan 2006
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Forty normal volunteers will be included. Normal volunteers would be recruited from people who are registered as HMCS Normal Volunteers. All subjects participating in this study should have a valid Clinical Center Medical Record Number. Procedures for the experiment will follow the Standard Operating Procedures of HMCS TMS group.
Who cannot join
- Contraindications for TMS;
- Magnetic stimulation will not be performed in people who have pacemakers, implanted pumps or stimulators, or have metal objects inside the eye or skull. If the participants find the procedures too uncomfortable, they may discontinue the study at any time. Brain functions at a development stage are out of scope of this particular experiment. In this study, subjects 18 years or older will be included.
- Contraindications for MRI;
- Pacemakers, brain stimulators, dental implants or metallic braces, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, insulin pump, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye which they may be unaware. Subjects will be screened for these contraindications prior to the study.
- Subjects with previous or current neuropsychiatric disorders will be excluded. Patients with MRI findings consistent with organic brain lesions such as brain tumors, stroke, or trauma will be excluded. Subjects not capable of giving informed consent will be excluded.
- We will not scan pregnant women with MRI because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subject of childbearing potential prior to MRI scan. Brain functions at a developmental stage are out of scope of this particular experiment. In this study, subjects aged 18 years or older will be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Role of Multimodal Areas for Sensory-To-Motor Processing
This study will use transcranial magnetic stimulation (TMS) to investigate functions of brain regions that may use information from sensory organs, such as the eyes or ears, to generate movements.
For TMS, a wire coil is held over the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. This may cause a pulling sensation on the skin under the coil and twitching in muscles of the face, arm, or leg. During the stimulation, the participant may be asked to tense certain muscles slightly or perform other simple actions.
Read more
Healthy normal volunteers 18 years of age and older may be eligible for this study. Individuals with a history of neuropsychiatric disorders, brain lesions such as tumors, stroke, or trauma, or a history of significant medical disorders, such as cancer, may not participate. Candidates will be screened with a medical history, brief physical examination, and questionnaire.
Participants will be presented a sequence of shapes (circles, rectangles, and triangle) and will count the number of a specified shape. Each number is assigned to a corresponding response button. The subject will push the appropriate button with the corresponding finger. During these experiments, the scalp will be stimulated by TMS. Each set of TMS measurements will take up to 3-1/2 hours.
Read the detailed description
The role of multimodal brain regions for sensory-to-motor processing is not well understood. In our recent neuroimaging study with fMRI, we found that multimodal areas such as the right superior temporal cortex and right dorsal premotor cortex were activated during sensory instructed movements. These regions might contribute to extract common features or concepts from sensory stimuli, but we do not have firm experimental evidence yet. In order to investigate the functional roles of multimodal brain regions further, we propose to apply a transcranial magnetic stimulation (TMS) technique. TMS can create transient brain lesions allowing functional mapping of cortical regions. In this protocol, by stimulating the multimodal areas using TMS, we will determine the functional role of these areas.
- Conditions
- Healthy
- Keywords
- Transcranial Magnetic Stimulation, Counting, Sensorimotor Integration, Superior Temporal Cortex, Dorsal Premotor Cortex, 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 posted24 Feb 2003 (estimated)
- Study startFeb 2003
- Study completionJan 2006
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
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055289
- Sponsor's protocol ID
- 030112
- Other IDs
- 03-N-0112
- Status last verified
- Jan 2006
- First submitted
- 22 Feb 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bremmer F, Schlack A, Shah NJ, Zafiris O, Kubischik M, Hoffmann K, Zilles K, Fink GR. Polymodal motion processing in posterior parietal and premotor cortex: a human fMRI study strongly implies equivalencies between humans and monkeys. Neuron. 2001 Jan;29(1):287-96. doi: 10.1016/s0896-6273(01)00198-2.
PubMed 11182099Calvert GA. Crossmodal processing in the human brain: insights from functional neuroimaging studies. Cereb Cortex. 2001 Dec;11(12):1110-23. doi: 10.1093/cercor/11.12.1110.
PubMed 11709482Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398.
PubMed 9153480
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Multimodal Areas for Sensory-To-Motor Processing
- ClinicalTrials.gov ID
- NCT00055289
- Acronym / sponsor ID
- 030112
- Conditions
- Healthy
- Keywords
- Transcranial Magnetic Stimulation, Counting, Sensorimotor Integration, Superior Temporal Cortex, Dorsal Premotor Cortex, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Feb 2003
- Study completion
- Jan 2006
- First posted
- 24 Feb 2003 (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 use transcranial magnetic stimulation (TMS) to investigate functions of brain regions that may use information from sensory organs, such as the eyes or ears, to generate movements.
For TMS, a wire coil is held over the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. This may cause a pulling sensation on the skin under the coil and twitching in muscles of the face, arm, or leg. During the stimulation, the participant may be asked to tense certain muscles slightly or perform other simple actions.
Healthy normal volunteers 18 years of age and older may be eligible for this study. Individuals with a history of neuropsychiatric disorders, brain lesions such as tumors, stroke, or trauma, or a history of significant medical disorders, such as cancer, may not participate. Candidates will be screened with a medical history, brief physical examination, and questionnaire.
Participants will be presented a sequence of shapes (circles, rectangles, and triangle) and will count the number of a specified shape. Each number is assigned to a corresponding response button. The subject will push the appropriate button with the corresponding finger. During these experiments, the scalp will be stimulated by TMS. Each set of TMS measurements will take up to 3-1/2 hours.
Detailed description
The role of multimodal brain regions for sensory-to-motor processing is not well understood. In our recent neuroimaging study with fMRI, we found that multimodal areas such as the right superior temporal cortex and right dorsal premotor cortex were activated during sensory instructed movements. These regions might contribute to extract common features or concepts from sensory stimuli, but we do not have firm experimental evidence yet. In order to investigate the functional roles of multimodal brain regions further, we propose to apply a transcranial magnetic stimulation (TMS) technique. TMS can create transient brain lesions allowing functional mapping of cortical regions. In this protocol, by stimulating the multimodal areas using TMS, we will determine the functional role of these areas.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Forty normal volunteers will be included. Normal volunteers would be recruited from people who are registered as HMCS Normal Volunteers. All subjects participating in this study should have a valid Clinical Center Medical Record Number. Procedures for the experiment will follow the Standard Operating Procedures of HMCS TMS group.
Key exclusion criteria (6 listed)
- Contraindications for TMS;
- Magnetic stimulation will not be performed in people who have pacemakers, implanted pumps or stimulators, or have metal objects inside the eye or skull. If the participants find the procedures too uncomfortable, they may discontinue the study at any time. Brain functions at a development stage are out of scope of this particular experiment. In this study, subjects 18 years or older will be included.
- Contraindications for MRI;
- Pacemakers, brain stimulators, dental implants or metallic braces, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, insulin pump, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye which they may be unaware. Subjects will be screened for these contraindications prior to the study.
- Subjects with previous or current neuropsychiatric disorders will be excluded. Patients with MRI findings consistent with organic brain lesions such as brain tumors, stroke, or trauma will be excluded. Subjects not capable of giving informed consent will be excluded.
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 4 Mar 2008.
- Background: PubMed 11182099Bremmer F, Schlack A, Shah NJ, Zafiris O, Kubischik M, Hoffmann K, Zilles K, Fink GR. Polymodal motion processing in posterior parietal and premotor cortex: a human fMRI study strongly implies equivalencies between humans and monkeys. Neuron. 2001 Jan;29(1):287-96. doi: 10.1016/s0896-6273(01)00198-2.
- Background: PubMed 11709482Calvert GA. Crossmodal processing in the human brain: insights from functional neuroimaging studies. Cereb Cortex. 2001 Dec;11(12):1110-23. doi: 10.1093/cercor/11.12.1110.
- Background: PubMed 9153480Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398.
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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 1 inclusion and 6 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 4 Mar 2008. 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 NCT00055289, 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 4 Mar 2008.