Dystonic DisordersNCT00050024
Transcranial Magnetic Stimulation and Electrical Stimulation of Nerves to Study Focal Dystonia
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 (TMS) and electrical stimulation of nerves to examine how the brain controls muscle movement in focal hand dystonia (writer's cramp). Normally, when a person moves a finger, the brain's motor cortex prevents the other fingers from moving involuntarily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dystonic Disorders
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2002to 17 Sep 2008
- 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
- Nineteen patients age 18 and over with focal dystonia of the upper limbs (writer's cramp) will be recruited for the study.
- For patients, the only selection criteria are the presence of focal hand dystonia.
- Nineteen normal subjects age 18 and over will be recruited for the control group.
- The controls will not have dystonia or any other neurological condition.
- All subjects will sign an informed consent prior to participation in the trial.
Who cannot join
- Exclusion criteria for the trial covering both the normal control and dystonia group will include any concurrent medical or surgical condition as well as neurological or psychiatric illnesses.
- Exclusion criteria will include any individual who is on medications with potential influence of the nervous system function (antidepressants, anxiolytics, anticonvulsants, antipsychotic, antiparkinson, hypnotics, stimulants, and antihistamines).
- The exclusion criteria also include patients who have received Botulinum toxin injection within 3 months of starting the protocol.
- Furthermore, any individual 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 Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Effect of Peripheral Heterotopic Stimulation on Cortical Excitability in Dystonia
This study will use transcranial magnetic stimulation (TMS) and electrical stimulation of nerves to examine how the brain controls muscle movement in focal hand dystonia (writer's cramp). Normally, when a person moves a finger, the brain's motor cortex prevents the other fingers from moving involuntarily. Patients with focal hand dystonia have difficulty with individualized finger movements, possibly due to increased excitability of the motor cortex. Musicians, writers, typists, athletes and others whose work involves frequent repetitive movements may develop focal dystonia of the hand.
Healthy normal volunteers and patients with focal dystonia 18 years of age and older may be eligible for this study.
Read more
For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. This 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 transient tingling in the forearm, head or face muscles. Subjects will be asked to move a finger. Just before this movement, a brief electrical stimulation will be applied to the end of either the second or fifth finger. Metal electrodes will be taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation. The testing will last 2-3 hours.
...
Read the detailed description
The purpose of this study is to investigate the effect of sensory afferent input on surround inhibition in the motor cortex in dystonia. 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 muscles, 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 sensory input on cortical surround inhibition, the phenomenon which we hypothesize to be defective in dystonia. The aim of this study then is to examine the changes in surround inhibition when electrical stimulation is applied to the finger being actively moved, leading to an inhibition of a surrounding finger (heterotopic inhibition), at different time intervals prior to the initiation of movement, to assess the effect of heterotopic peripheral stimulation on surround inhibition in dystonia patients compared to normal subjects.
- Conditions
- Dystonic Disorders
- Keywords
- TMS, Afferent Stimulation, Motor Cortex, Writer's Cramp, Surround Inhibition, Heterotopic Inhibition, Focal Dystonia, Writer Cramp
- 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 posted20 Nov 2002 (estimated)
- Study start13 Nov 2002
- Study completion17 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 38 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050024
- Sponsor's protocol ID
- 030048
- Other IDs
- 03-N-0048
- Status last verified
- 17 Sep 2008
- First submitted
- 19 Nov 2002
- Last updated
- 2 Jul 2017
- 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 11222454Hallett M. Transcranial magnetic stimulation and the human brain. Nature. 2000 Jul 13;406(6792):147-50. doi: 10.1038/35018000.
PubMed 10910346Ahmad F, McPhie P. The denaturation of covalently inhibited swine pepsin. Int J Pept Protein Res. 1978 Sep;12(3):155-63. doi: 10.1111/j.1399-3011.1978.tb02879.x.
PubMed 29843Hallett M. Is dystonia a sensory disorder? Ann Neurol. 1995 Aug;38(2):139-40. doi: 10.1002/ana.410380203. No abstract available.
PubMed 7654059
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 Effect of Peripheral Heterotopic Stimulation on Cortical Excitability in Dystonia
- ClinicalTrials.gov ID
- NCT00050024
- Acronym / sponsor ID
- 030048
- Conditions
- Dystonic Disorders
- Keywords
- TMS, Afferent Stimulation, Motor Cortex, Writer's Cramp, Surround Inhibition, Heterotopic Inhibition, Focal Dystonia, Writer Cramp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 13 Nov 2002
- Study completion
- 17 Sep 2008
- First posted
- 20 Nov 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 (TMS) and electrical stimulation of nerves to examine how the brain controls muscle movement in focal hand dystonia (writer's cramp). Normally, when a person moves a finger, the brain's motor cortex prevents the other fingers from moving involuntarily. Patients with focal hand dystonia have difficulty with individualized finger movements, possibly due to increased excitability of the motor cortex. Musicians, writers, typists, athletes and others whose work involves frequent repetitive movements may develop focal dystonia of the hand.
Healthy normal volunteers and patients with focal dystonia 18 years of age and older may be eligible for this study.
For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. This 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 transient tingling in the forearm, head or face muscles. Subjects will be asked to move a finger. Just before this movement, a brief electrical stimulation will be applied to the end of either the second or fifth finger. Metal electrodes will be taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation. The testing will last 2-3 hours.
...
Detailed description
The purpose of this study is to investigate the effect of sensory afferent input on surround inhibition in the motor cortex in dystonia. 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 muscles, 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 sensory input on cortical surround inhibition, the phenomenon which we hypothesize to be defective in dystonia. The aim of this study then is to examine the changes in surround inhibition when electrical stimulation is applied to the finger being actively moved, leading to an inhibition of a surrounding finger (heterotopic inhibition), at different time intervals prior to the initiation of movement, to assess the effect of heterotopic peripheral stimulation on surround inhibition in dystonia patients compared to normal subjects.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Nineteen patients age 18 and over with focal dystonia of the upper limbs (writer's cramp) will be recruited for the study.
- For patients, the only selection criteria are the presence of focal hand dystonia.
- Nineteen normal subjects age 18 and over will be recruited for the control group.
- The controls will not have dystonia or any other neurological condition.
- All subjects will sign an informed consent prior to participation in the trial.
Key exclusion criteria (4 listed)
- Exclusion criteria for the trial covering both the normal control and dystonia group will include any concurrent medical or surgical condition as well as neurological or psychiatric illnesses.
- Exclusion criteria will include any individual who is on medications with potential influence of the nervous system function (antidepressants, anxiolytics, anticonvulsants, antipsychotic, antiparkinson, hypnotics, stimulants, and antihistamines).
- The exclusion criteria also include patients who have received Botulinum toxin injection within 3 months of starting the protocol.
- Furthermore, any individual 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 2 Jul 2017.
- 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 10910346Hallett M. Transcranial magnetic stimulation and the human brain. Nature. 2000 Jul 13;406(6792):147-50. doi: 10.1038/35018000.
- Background: PubMed 29843Ahmad F, McPhie P. The denaturation of covalently inhibited swine pepsin. Int J Pept Protein Res. 1978 Sep;12(3):155-63. doi: 10.1111/j.1399-3011.1978.tb02879.x.
- Background: PubMed 7654059Hallett M. Is dystonia a sensory disorder? Ann Neurol. 1995 Aug;38(2):139-40. doi: 10.1002/ana.410380203. No abstract available.
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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 5 inclusion and 4 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 NCT00050024, which also lists 4 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.