Healthy VolunteersNCT00726050
Brain Activity in Time Discrimination and Sensory Input
An observational study of Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use repetitive transcranial magnetic stimulation, or rTMS (magnetic stimulation to the brain), to examine how the brain distinguishes between two signals that are spaced very closely in time. The ability to tell the difference between sensory signals is important to understanding sensory input. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2008to 29 Apr 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Absence of dystonia or other neurological conditions
Who cannot join
- Concurrent medical, surgical, neurologic or psychiatric condition
- History of neurological disorders
- History of seizure disorder
- Pregnant women
- Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
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: The Relationship Between Temporal Discrimination and Cortical Excitability in Humans
This study will use repetitive transcranial magnetic stimulation, or rTMS (magnetic stimulation to the brain), to examine how the brain distinguishes between two signals that are spaced very closely in time. The ability to tell the difference between sensory signals is important to understanding sensory input. Understanding how this works may help to develop new treatments for sensory deficits.
Healthy volunteers 18 years of age and older may be eligible for this study. Participants undergo the following procedures during three visits to the NIH Clinical Center:
Read more
rTMS - all visits (sham rTMS on one visit) :
For TMS, a wire coil is held on the scalp. A brief electrical current passed through the coil creates a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions.
Theta burst stimulation (TBS) - all visits (sham TBS on one visit):
Same as TMS, but brief pulses of electrical current are passed through the coil. Subjects undergo intermittent TBS on one visit and continuous TBS on another.
Somatosensory evoked potential (SEP) - all visits:
SEP tests how sensory information travels along the nerves to the spinal cord and brain. A small metal disk electrode placed on an arm delivers a small electrical shock. Electrodes placed on the scalp record how the impulse travels over the nerve pathways to the cerebral cortex of the brain. EEG (see below) records what sensory information the brain is detecting and processing. Paired-pulse SEP is done before and after TBS.
Temporal discrimination threshold - all visits:
This test investigates the brain's ability to discriminate sensory information. Electrodes are placed on the subject's wrist. Two electrical pulses are delivered to the nerve at the wrist at different spaced intervals to determine when the subject feels the two pulses are fused into one. This test is done before and after TBS.
Electroencephalography (EEG) - all visits:
This test records brain waves (electrical activity of the brain). Electrodes are placed on the scalp with an electrode cap. The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity.
Read the detailed description
Objective:
The ability to discriminate successive signals separated by time intervals in the millisecond-range is an important element in analyzing the temporal characteristics of sensory input. When two identical stimuli are presented with a sufficient time interval between them, they are readily perceived as being two separate events. As they are presented progressively closer together, there comes a point when the two separate stimuli are perceived as one. However, the neural mechanism of temporal discrimination is unclear. Therefore, our major objective is to analyze, in detail, the effect of cortical excitability and inhibition on temporal sensory discrimination in healthy subjects.
Study Population:
We intend to study 25 adult healthy volunteers.
Design:
Assuming the cortical circuit in the somatosensory area plays an important role in temporal discrimination, we plan to investigate the relationship between cortical excitability and the ability of temporal discrimination. We hypothesize that the extent of cortical excitability affects the ability to discriminate. Cortical excitability will be modulated by using repetitive transcranial magnetic stimulation (rTMS). Comparison of cortical excitability changes will be determined before and after rTMS in the primary somatosensory cortex (SI). The change in cortical information processing in SI will be studied using multi-channel electroencephalography (EEG) recording of paired-pulse somatosensory evoked potentials (SEPs) delivered at rest. Activity assessment in the cortical circuit will be measured by the recovery curve of the amplitude of paired-pulse SEPs.
Outcome Measures:
The primary outcome measure will be the change in amplitude of the paired-pulse SEP component (P27) in 5-ms interstimulus interval condition for three types of rTMS. The secondary outcome will be the amplitude of paired-pulse SEP components during other interstimulus interval conditions (10 to 200 ms).
- Conditions
- Healthy Volunteers
- Keywords
- Theta Burst Stimulation, Somatosensory Stimulation, Somatosensory Cortex, Tactile Discrimination, 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 posted31 Jul 2008 (estimated)
- Study start28 Jul 2008
- Study completion29 Apr 2010
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 Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726050
- Sponsor's protocol ID
- 080189
- Other IDs
- 08-N-0189
- Status last verified
- 29 Apr 2010
- First submitted
- 30 Jul 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Aglioti SM, Fiorio M, Forster B, Tinazzi M. Temporal discrimination of cross-modal and unimodal stimuli in generalized dystonia. Neurology. 2003 Mar 11;60(5):782-5. doi: 10.1212/01.wnl.0000046528.24693.5b.
PubMed 12629233Akatsuka K, Wasaka T, Nakata H, Inui K, Hoshiyama M, Kakigi R. Mismatch responses related to temporal discrimination of somatosensory stimulation. Clin Neurophysiol. 2005 Aug;116(8):1930-7. doi: 10.1016/j.clinph.2005.04.021.
PubMed 15982927Angel A. Cortical responses to paired stimuli applied peripherally & at sites along the somato-sensory pathway. J Physiol. 1967 Jul;191(2):427-48. doi: 10.1113/jphysiol.1967.sp008260.
PubMed 6050113
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
- The Relationship Between Temporal Discrimination and Cortical Excitability in Humans
- ClinicalTrials.gov ID
- NCT00726050
- Acronym / sponsor ID
- 080189
- Conditions
- Healthy Volunteers
- Keywords
- Theta Burst Stimulation, Somatosensory Stimulation, Somatosensory Cortex, Tactile Discrimination, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 28 Jul 2008
- Study completion
- 29 Apr 2010
- First posted
- 31 Jul 2008 (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 repetitive transcranial magnetic stimulation, or rTMS (magnetic stimulation to the brain), to examine how the brain distinguishes between two signals that are spaced very closely in time. The ability to tell the difference between sensory signals is important to understanding sensory input. Understanding how this works may help to develop new treatments for sensory deficits.
Healthy volunteers 18 years of age and older may be eligible for this study. Participants undergo the following procedures during three visits to the NIH Clinical Center:
rTMS - all visits (sham rTMS on one visit) :
For TMS, a wire coil is held on the scalp. A brief electrical current passed through the coil creates a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions.
Theta burst stimulation (TBS) - all visits (sham TBS on one visit):
Same as TMS, but brief pulses of electrical current are passed through the coil. Subjects undergo intermittent TBS on one visit and continuous TBS on another.
Somatosensory evoked potential (SEP) - all visits:
SEP tests how sensory information travels along the nerves to the spinal cord and brain. A small metal disk electrode placed on an arm delivers a small electrical shock. Electrodes placed on the scalp record how the impulse travels over the nerve pathways to the cerebral cortex of the brain. EEG (see below) records what sensory information the brain is detecting and processing. Paired-pulse SEP is done before and after TBS.
Temporal discrimination threshold - all visits:
This test investigates the brain's ability to discriminate sensory information. Electrodes are placed on the subject's wrist. Two electrical pulses are delivered to the nerve at the wrist at different spaced intervals to determine when the subject feels the two pulses are fused into one. This test is done before and after TBS.
Electroencephalography (EEG) - all visits:
This test records brain waves (electrical activity of the brain). Electrodes are placed on the scalp with an electrode cap. The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity.
Detailed description
Objective:
The ability to discriminate successive signals separated by time intervals in the millisecond-range is an important element in analyzing the temporal characteristics of sensory input. When two identical stimuli are presented with a sufficient time interval between them, they are readily perceived as being two separate events. As they are presented progressively closer together, there comes a point when the two separate stimuli are perceived as one. However, the neural mechanism of temporal discrimination is unclear. Therefore, our major objective is to analyze, in detail, the effect of cortical excitability and inhibition on temporal sensory discrimination in healthy subjects.
Study Population:
We intend to study 25 adult healthy volunteers.
Design:
Assuming the cortical circuit in the somatosensory area plays an important role in temporal discrimination, we plan to investigate the relationship between cortical excitability and the ability of temporal discrimination. We hypothesize that the extent of cortical excitability affects the ability to discriminate. Cortical excitability will be modulated by using repetitive transcranial magnetic stimulation (rTMS). Comparison of cortical excitability changes will be determined before and after rTMS in the primary somatosensory cortex (SI). The change in cortical information processing in SI will be studied using multi-channel electroencephalography (EEG) recording of paired-pulse somatosensory evoked potentials (SEPs) delivered at rest. Activity assessment in the cortical circuit will be measured by the recovery curve of the amplitude of paired-pulse SEPs.
Outcome Measures:
The primary outcome measure will be the change in amplitude of the paired-pulse SEP component (P27) in 5-ms interstimulus interval condition for three types of rTMS. The secondary outcome will be the amplitude of paired-pulse SEP components during other interstimulus interval conditions (10 to 200 ms).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years and older
- Absence of dystonia or other neurological conditions
Key exclusion criteria (5 listed)
- Concurrent medical, surgical, neurologic or psychiatric condition
- History of neurological disorders
- History of seizure disorder
- Pregnant women
- Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
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 12629233Aglioti SM, Fiorio M, Forster B, Tinazzi M. Temporal discrimination of cross-modal and unimodal stimuli in generalized dystonia. Neurology. 2003 Mar 11;60(5):782-5. doi: 10.1212/01.wnl.0000046528.24693.5b.
- Background: PubMed 15982927Akatsuka K, Wasaka T, Nakata H, Inui K, Hoshiyama M, Kakigi R. Mismatch responses related to temporal discrimination of somatosensory stimulation. Clin Neurophysiol. 2005 Aug;116(8):1930-7. doi: 10.1016/j.clinph.2005.04.021.
- Background: PubMed 6050113Angel A. Cortical responses to paired stimuli applied peripherally & at sites along the somato-sensory pathway. J Physiol. 1967 Jul;191(2):427-48. doi: 10.1113/jphysiol.1967.sp008260.
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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 Volunteers, 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 NCT00726050, 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.