Dystonic DisordersNCT00047957
Brain Inhibition of Muscle Movement in Normal Volunteers
An observational study of Dystonic Disorders, 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, or TMS (described below), to examine how the brain controls muscle movement to prevent unwanted movements in surrounding muscles. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dystonic Disorders
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Sep 2005
- 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
- Twenty healthy volunteers older than age 18 will be recruited for the study. Their gender, age, or ethnic origin will not provide bias for inclusion to the study. All subjects will sign an informed consent prior to participation in the trial.
Who cannot join
- Exclusion criteria for the trial will include any current medical or surgical condition or neurological or psychiatric illnesses. Furthermore, any individual who is on medication with potential influence on nervous system function, who has a pacemaker, an implanted medical pump, a metal plate or metal object in the skull or eye (for example, after brain surgery), or who has a history of seizure disorder will be excluded from the trial.
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: The Effect of Peripheral Homotopic and Heterotopic Stimulation on Cortical Excitability
This study will use transcranial magnetic stimulation, or TMS (described below), to examine how the brain controls muscle movement to prevent unwanted movements in surrounding muscles. For example, when a person moves a finger, a part of the brain called the cortex prevents unwanted movements in other fingers by a process called cortical inhibition. In people with the muscle disorder dystonia, cortical inhibition does not work properly and patients suffer from uncontrolled and sometimes painful movements. A better understanding of how this process works in normal people may shed light on what goes wrong in dystonia and how the condition can be treated.
Healthy normal volunteers 19 years of age and older may be eligible for this study. Candidates will be screened with a medical history and physical and neurological examinations. People with a current medical or surgical condition or neurological or psychiatric illness may not participate, nor may individuals who are taking medication that may influence nervous system function.
Read more
Participants will undergo TMS to record the electrical activity of muscles in the hand and arm that are activated by magnetic stimulation. For the procedure, subjects are seated in a chair with their hands placed on a pillow in their laps. A wire coil in placed on their scalps. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. Subjects will be asked to move their second finger in response to a loud beep or visual cue. In some trials, a brief, mild electrical shock will also be applied to the end of either the second or fifth finger. The shock is not painful.
TMS may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may induce twitches or temporary tingling in the forearm, head, or face muscles. The twitching may cause mild discomfort, but the procedure is rarely considered painful.
Read the detailed description
The purpose of this study is to investigate the effect of homotopic and heterotopic sensory afferent input on surround inhibition in the motor cortex. Surround inhibition is a cortical phenomenon, the function of which may be to suppress unwanted movements in surrounding muscles during voluntary actions. In support of this, a recent study showed that motor output to the little finger was reduced during self-paced, voluntary movements of the index finger, despite an increase in spinal excitability. Work has also shown that in relaxed muscle, homotopic and heterotopic peripheral stimulation results in time dependent modulation of motor cortical excitability. However, no studies have examined the relationship between volitional movement and afferent sensory input on cortical surround inhibition. Therefore, the aim of this study is to examine the changes in surround inhibition when electrical stimulation is applied to either the finger being actively moved (homotopic stimulation) or a separate finger not involved in the movement (heterotopic stimulation) at different time periods prior to the initiation of movements to assess the affect of these stimuli on surround inhibition and excitation in the motor cortex.
- Conditions
- Dystonic Disorders
- Keywords
- Transcranial, Magnetic, Stimulation, Motor, Cortex, Motor Cortex, Afferent Stimulation, Transcranial Magnetic Stimulation, Healthy Volunteer, HV
- Medical subject headings
- Dystonic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2002 (estimated)
- Study startOct 2002
- Study completionSep 2005
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 Dystonic DisordersStudies 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
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047957
- Sponsor's protocol ID
- 030008
- Other IDs
- 03-N-0008
- Status last verified
- Sep 2005
- First submitted
- 22 Oct 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Abbruzzese G, Marchese R, Buccolieri A, Gasparetto B, Trompetto C. Abnormalities of sensorimotor integration in focal dystonia: a transcranial magnetic stimulation study. Brain. 2001 Mar;124(Pt 3):537-45. doi: 10.1093/brain/124.3.537.
PubMed 11222454Classen J, Steinfelder B, Liepert J, Stefan K, Celnik P, Cohen LG, Hess A, Kunesch E, Chen R, Benecke R, Hallett M. Cutaneomotor integration in humans is somatotopically organized at various levels of the nervous system and is task dependent. Exp Brain Res. 2000 Jan;130(1):48-59. doi: 10.1007/s002210050005.
PubMed 10638440Hallett M. Transcranial magnetic stimulation and the human brain. Nature. 2000 Jul 13;406(6792):147-50. doi: 10.1038/35018000.
PubMed 10910346
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
- The Effect of Peripheral Homotopic and Heterotopic Stimulation on Cortical Excitability
- ClinicalTrials.gov ID
- NCT00047957
- Acronym / sponsor ID
- 030008
- Conditions
- Dystonic Disorders
- Keywords
- Transcranial, Magnetic, Stimulation, Motor, Cortex, Motor Cortex, Afferent Stimulation, Transcranial Magnetic Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 2002
- Study completion
- Sep 2005
- First posted
- 23 Oct 2002 (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, or TMS (described below), to examine how the brain controls muscle movement to prevent unwanted movements in surrounding muscles. For example, when a person moves a finger, a part of the brain called the cortex prevents unwanted movements in other fingers by a process called cortical inhibition. In people with the muscle disorder dystonia, cortical inhibition does not work properly and patients suffer from uncontrolled and sometimes painful movements. A better understanding of how this process works in normal people may shed light on what goes wrong in dystonia and how the condition can be treated.
Healthy normal volunteers 19 years of age and older may be eligible for this study. Candidates will be screened with a medical history and physical and neurological examinations. People with a current medical or surgical condition or neurological or psychiatric illness may not participate, nor may individuals who are taking medication that may influence nervous system function.
Participants will undergo TMS to record the electrical activity of muscles in the hand and arm that are activated by magnetic stimulation. For the procedure, subjects are seated in a chair with their hands placed on a pillow in their laps. A wire coil in placed on their scalps. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. Subjects will be asked to move their second finger in response to a loud beep or visual cue. In some trials, a brief, mild electrical shock will also be applied to the end of either the second or fifth finger. The shock is not painful.
TMS may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may induce twitches or temporary tingling in the forearm, head, or face muscles. The twitching may cause mild discomfort, but the procedure is rarely considered painful.
Detailed description
The purpose of this study is to investigate the effect of homotopic and heterotopic sensory afferent input on surround inhibition in the motor cortex. Surround inhibition is a cortical phenomenon, the function of which may be to suppress unwanted movements in surrounding muscles during voluntary actions. In support of this, a recent study showed that motor output to the little finger was reduced during self-paced, voluntary movements of the index finger, despite an increase in spinal excitability. Work has also shown that in relaxed muscle, homotopic and heterotopic peripheral stimulation results in time dependent modulation of motor cortical excitability. However, no studies have examined the relationship between volitional movement and afferent sensory input on cortical surround inhibition. Therefore, the aim of this study is to examine the changes in surround inhibition when electrical stimulation is applied to either the finger being actively moved (homotopic stimulation) or a separate finger not involved in the movement (heterotopic stimulation) at different time periods prior to the initiation of movements to assess the affect of these stimuli on surround inhibition and excitation in the motor cortex.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Twenty healthy volunteers older than age 18 will be recruited for the study. Their gender, age, or ethnic origin will not provide bias for inclusion to the study. All subjects will sign an informed consent prior to participation in the trial.
Key exclusion criteria (1 listed)
- Exclusion criteria for the trial will include any current medical or surgical condition or neurological or psychiatric illnesses. Furthermore, any individual who is on medication with potential influence on nervous system function, who has a pacemaker, an implanted medical pump, a metal plate or metal object in the skull or eye (for example, after brain surgery), or who has a history of seizure disorder will be excluded from the trial.
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 11222454Abbruzzese G, Marchese R, Buccolieri A, Gasparetto B, Trompetto C. Abnormalities of sensorimotor integration in focal dystonia: a transcranial magnetic stimulation study. Brain. 2001 Mar;124(Pt 3):537-45. doi: 10.1093/brain/124.3.537.
- Background: PubMed 10638440Classen J, Steinfelder B, Liepert J, Stefan K, Celnik P, Cohen LG, Hess A, Kunesch E, Chen R, Benecke R, Hallett M. Cutaneomotor integration in humans is somatotopically organized at various levels of the nervous system and is task dependent. Exp Brain Res. 2000 Jan;130(1):48-59. doi: 10.1007/s002210050005.
- Background: PubMed 10910346Hallett M. Transcranial magnetic stimulation and the human brain. Nature. 2000 Jul 13;406(6792):147-50. doi: 10.1038/35018000.
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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 Dystonic Disorders, 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 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 NCT00047957, 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.