HealthyNCT00067223
Studying Use-Dependent Plasticity
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Recent studies suggest that when patients learn a new motor movement, it may cause a change in the way the nerves act in the area of the brain that controls that movement. This change is called use-dependent plasticity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2003to 25 Jun 2007
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only healthy volunteers 18 years or older will be included in this protocol. Handedness will be assessed by the Edinburgh Inventory Scale. All experimental sessions will be studied on outpatient basis. Normal Volunteers with right-handedness will be eligible to participate.
Who cannot join
- Subjects with the history of epilepsy, surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, neural stimulators, cochlear implants, history of drug abuse, psychiatric illness (depression), hypertension or use of medications that influence synaptic plasticity, will be excluded as evaluated by the investigator.
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: Bi-hemispheric Plasticity Elicited By Unilateral Finger Motor Training
Recent studies suggest that when patients learn a new motor movement, it may cause a change in the way the nerves act in the area of the brain that controls that movement. This change is called use-dependent plasticity.
The purpose of this study is to determine the direction and extent of the changes that take place in the brain areas that control movement in the untrained finger after the training of the opposite finger. The study outcomes may help researchers to develop rehabilitation strategies for people who have suffered brain injuries.
Eighteen healthy adults age 18 years or older will be enrolled in this study. Participants will undergo a clinical exam and then come back to the Clinical Center three times for sessions that will last approximately 2 hours each. For each session, participants' forearms will be immobilized and a small electronic device will be attached to each index finger so that researchers can measure their movements. Participants will be asked to move either index finger and to observe and concentrate on its movement. Investigators will perform transcranial magnetic stimulation (TMS) before and after these motor exercises. For TMS, a wire coil is held over the scalp and a brief electrical current passes through the coil, creating a magnetic pulse that electrically stimulates the brain.
Read the detailed description
Motor training consisting of repetition of unilateral finger movements leads to use-dependent plasticity (UDP) in the contralateral primary motor cortex, M1, in normal volunteers. It is conceivable that motor training in one hand, in addition to changes in the contralateral M1, could elicit plastic changes in the ipsilateral M1. The purpose of this study is to test this hypothesis: Training consisting of repetition of a unilateral finger movement elicits plastic changes in the cortical representation of the homonymous untrained finger in the ipsilateral M1. The study will be performed on normal volunteers and will consist of three to five separate training sessions. The endpoint measure will be, for each session, the change in the direction of the movements evoked by TMS in the untrained index finger as a function of the opposite index finger.
- Conditions
- Healthy
- Keywords
- Transcranial Magnetic Stimulation (TMS), Unilateral Finger Movement, Interhemispheric Inhibition, Motor Training, Plasticity, 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 posted13 Aug 2003 (estimated)
- Study start5 Aug 2003
- Study completion25 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 28 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067223
- Sponsor's protocol ID
- 030273
- Other IDs
- 03-N-0273
- Status last verified
- 25 Jun 2007
- First submitted
- 12 Aug 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Liepert J, Dettmers C, Terborg C, Weiller C. Inhibition of ipsilateral motor cortex during phasic generation of low force. Clin Neurophysiol. 2001 Jan;112(1):114-21. doi: 10.1016/s1388-2457(00)00503-4.
PubMed 11137668
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
- Bi-hemispheric Plasticity Elicited By Unilateral Finger Motor Training
- ClinicalTrials.gov ID
- NCT00067223
- Acronym / sponsor ID
- 030273
- Conditions
- Healthy
- Keywords
- Transcranial Magnetic Stimulation (TMS), Unilateral Finger Movement, Interhemispheric Inhibition, Motor Training, Plasticity, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 5 Aug 2003
- Study completion
- 25 Jun 2007
- First posted
- 13 Aug 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.
Recent studies suggest that when patients learn a new motor movement, it may cause a change in the way the nerves act in the area of the brain that controls that movement. This change is called use-dependent plasticity.
The purpose of this study is to determine the direction and extent of the changes that take place in the brain areas that control movement in the untrained finger after the training of the opposite finger. The study outcomes may help researchers to develop rehabilitation strategies for people who have suffered brain injuries.
Eighteen healthy adults age 18 years or older will be enrolled in this study. Participants will undergo a clinical exam and then come back to the Clinical Center three times for sessions that will last approximately 2 hours each. For each session, participants' forearms will be immobilized and a small electronic device will be attached to each index finger so that researchers can measure their movements. Participants will be asked to move either index finger and to observe and concentrate on its movement. Investigators will perform transcranial magnetic stimulation (TMS) before and after these motor exercises. For TMS, a wire coil is held over the scalp and a brief electrical current passes through the coil, creating a magnetic pulse that electrically stimulates the brain.
Detailed description
Motor training consisting of repetition of unilateral finger movements leads to use-dependent plasticity (UDP) in the contralateral primary motor cortex, M1, in normal volunteers. It is conceivable that motor training in one hand, in addition to changes in the contralateral M1, could elicit plastic changes in the ipsilateral M1. The purpose of this study is to test this hypothesis: Training consisting of repetition of a unilateral finger movement elicits plastic changes in the cortical representation of the homonymous untrained finger in the ipsilateral M1. The study will be performed on normal volunteers and will consist of three to five separate training sessions. The endpoint measure will be, for each session, the change in the direction of the movements evoked by TMS in the untrained index finger as a function of the opposite index finger.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only healthy volunteers 18 years or older will be included in this protocol. Handedness will be assessed by the Edinburgh Inventory Scale. All experimental sessions will be studied on outpatient basis. Normal Volunteers with right-handedness will be eligible to participate.
Key exclusion criteria (1 listed)
- Subjects with the history of epilepsy, surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, neural stimulators, cochlear implants, history of drug abuse, psychiatric illness (depression), hypertension or use of medications that influence synaptic plasticity, will be excluded as evaluated by the investigator.
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 11137668Liepert J, Dettmers C, Terborg C, Weiller C. Inhibition of ipsilateral motor cortex during phasic generation of low force. Clin Neurophysiol. 2001 Jan;112(1):114-21. doi: 10.1016/s1388-2457(00)00503-4.
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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 1 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 NCT00067223, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 2 Nov 2026.