Focal DystoniaNCT00309010
Neurophysiology of Task-Specificity of Focal Hand Dystonia
An observational study of Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how the brain coordinates movement in patients with focal hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Focal Dystonia
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2006to 24 Feb 2009
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Age over 18 years
- Presence of FHD, specifically writer's cramp
- Healthy volunteers:
- Age over 18 years
- Absence of dystonia or other neurologic condition
Who cannot join
- Patients and Healthy volunteers:
- Concurrent medical, surgical, neurologic or psychiatric condition
- Taking medications which include antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
- Received botulinum toxin injection within 3 months of starting the protocol
- Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
- History of seizure disorder
Show all 9Show fewer
- For healthy volunteers undergoing MRI, subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI and/or current pregnancy
- A serious medical illness which prevents them from lying flat for up to 60 minutes
- Claustrophobia (a fear of tight spaces), which prevents them from lying still in a tight or small space for up to 60 minutes
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
This study will examine how the brain coordinates movement in patients with focal hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. This study will use transcranial magnetic stimulation (TMS, see below) to study how the brain plans movement.
Healthy volunteers and patients with focal hand dystonia 18 years of age and older may be eligible for this study. Healthy subjects may participate in one, two or three of the experiments described below. Patients with dystonia may participate in experiments one and three.
Read more
Before each experiment, each subject is asked about his/her medical and neurologic history, complete questionnaires and will undergo a brief physical examination.
Experiment 1
- Surface EMG: Small electrodes are taped to the skin over the arm to measure the electrical activity of muscles.
- TMS: A wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating 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. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil.
Experiment 2 (Two visits.)
- Visit 1: Magnetic resonance imaging (MRI): This test uses a magnetic field and radio waves to obtain images of body tissues and organs. The patient lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient will be asked to lie still for up to 30 minutes at a time.
- Visit 2: Surface EMG and TMS
Experiment 3
-Surface EMG and TMS - During the TMS, subjects are asked to respond to shapes on a computer screen by pushing a button or pressing a foot petal.
Read the detailed description
Objective
Currently, there is no cure for focal hand dystonia (FHD). FHD research has focused predominantly on the motor execution abnormality in the primary motor cortex, while the task-specific nature of FHD has received less attention. Task-specificity suggests that the underlying task-to-motor output relationship is intact for many activities and dysfunctional for an important minority of tasks. The premotor cortex plays a key role in this relationship in health and, likely, plays an equally important role in disordered movement. The goal for this research proposal is to understand the underlying physiology and contribution of the premotor cortex in FHD.
Study population
We intend to study adult patients with FHD and healthy volunteers on an outpatient basis. In a task-specific dystonia of the hand known as writer's cramp, handwriting is abnormal due to posturing and muscle spasm, whereas other tasks done with the affected hand are normal. The disordered relationship between task-to-motor output in FHD is potentially modifiable if the correct target and therapeutic modality are identified.
Design
In a series of three experiments, we propose to use transcranial magnetic stimulation (TMS) to examine the circuitry of the premotor to motor cortex connections in FHD, to interrupt motor planning in FHD, and to define premotor cortex somatotopy. In Experiment 1, TMS will be used to test the hypothesis that there is deficient inhibition from premotor to motor cortex in patients with FHD at rest, during voluntary movement and while maintaining a task-specific position. In Experiment 2, TMS will be used to identify whether there is a somatotopic organization relevant to the inhibitory premotor-motor cortex interaction in healthy volunteers. In Experiment 3, to address the role of motor planning dysfunction in the task-specific nature of FHD, we will use TMS to evaluate the premotor-motor cortex inhibition during a reaction time task.
Outcome measures
The primary outcome measure of Experiment 1 will be change in MEP peak-to-peak amplitude between patients and healthy volunteers at rest and in two motor conditions. In Experiment 2, the primary outcome measure will be the location of the TMS coil for optimizing inhibition from leg premotor cortex to motor cortex compared to the coil location from arm premotor cortex to motor cortex. Finally, in Experiment 3, the primary outcome measure will be the change in reaction time from baseline to the test condition with transient TMS-induced interruption in premotor cortex function.
- Conditions
- Focal Dystonia
- Keywords
- Focal Hand Dystonia, Motor Planning, Transcranial Magnetic Stimulation (TMS), MRI (Magnetic Resonance Imaging), FHD, Writer's Cramp, Healthy Volunteer, HV
- Medical subject headings
- Dystonic Disorders, Dystonia, Focal, Task-Specific
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study start28 Mar 2006
- Study completion24 Feb 2009
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 Focal DystoniaStudies 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
- 115 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309010
- Sponsor's protocol ID
- 060126
- Other IDs
- 06-N-0126
- Status last verified
- 24 Feb 2009
- First submitted
- 29 Mar 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Hallett M. Dystonia: abnormal movements result from loss of inhibition. Adv Neurol. 2004;94:1-9. No abstract available.
PubMed 14509648Bressman SB. Dystonia genotypes, phenotypes, and classification. Adv Neurol. 2004;94:101-7. No abstract available.
PubMed 14509661Chen R, Hallett M. Focal dystonia and repetitive motion disorders. Clin Orthop Relat Res. 1998 Jun;(351):102-6.
PubMed 9646753
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
- Neurophysiology of Task-Specificity of Focal Hand Dystonia
- ClinicalTrials.gov ID
- NCT00309010
- Acronym / sponsor ID
- 060126
- Conditions
- Focal Dystonia
- Keywords
- Focal Hand Dystonia, Motor Planning, Transcranial Magnetic Stimulation (TMS), MRI (Magnetic Resonance Imaging), FHD, Writer's Cramp, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 28 Mar 2006
- Study completion
- 24 Feb 2009
- First posted
- 30 Mar 2006 (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 examine how the brain coordinates movement in patients with focal hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. This study will use transcranial magnetic stimulation (TMS, see below) to study how the brain plans movement.
Healthy volunteers and patients with focal hand dystonia 18 years of age and older may be eligible for this study. Healthy subjects may participate in one, two or three of the experiments described below. Patients with dystonia may participate in experiments one and three.
Before each experiment, each subject is asked about his/her medical and neurologic history, complete questionnaires and will undergo a brief physical examination.
Experiment 1
- Surface EMG: Small electrodes are taped to the skin over the arm to measure the electrical activity of muscles.
- TMS: A wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating 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. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil.
Experiment 2 (Two visits.)
- Visit 1: Magnetic resonance imaging (MRI): This test uses a magnetic field and radio waves to obtain images of body tissues and organs. The patient lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient will be asked to lie still for up to 30 minutes at a time.
- Visit 2: Surface EMG and TMS
Experiment 3
-Surface EMG and TMS - During the TMS, subjects are asked to respond to shapes on a computer screen by pushing a button or pressing a foot petal.
Detailed description
Objective
Currently, there is no cure for focal hand dystonia (FHD). FHD research has focused predominantly on the motor execution abnormality in the primary motor cortex, while the task-specific nature of FHD has received less attention. Task-specificity suggests that the underlying task-to-motor output relationship is intact for many activities and dysfunctional for an important minority of tasks. The premotor cortex plays a key role in this relationship in health and, likely, plays an equally important role in disordered movement. The goal for this research proposal is to understand the underlying physiology and contribution of the premotor cortex in FHD.
Study population
We intend to study adult patients with FHD and healthy volunteers on an outpatient basis. In a task-specific dystonia of the hand known as writer's cramp, handwriting is abnormal due to posturing and muscle spasm, whereas other tasks done with the affected hand are normal. The disordered relationship between task-to-motor output in FHD is potentially modifiable if the correct target and therapeutic modality are identified.
Design
In a series of three experiments, we propose to use transcranial magnetic stimulation (TMS) to examine the circuitry of the premotor to motor cortex connections in FHD, to interrupt motor planning in FHD, and to define premotor cortex somatotopy. In Experiment 1, TMS will be used to test the hypothesis that there is deficient inhibition from premotor to motor cortex in patients with FHD at rest, during voluntary movement and while maintaining a task-specific position. In Experiment 2, TMS will be used to identify whether there is a somatotopic organization relevant to the inhibitory premotor-motor cortex interaction in healthy volunteers. In Experiment 3, to address the role of motor planning dysfunction in the task-specific nature of FHD, we will use TMS to evaluate the premotor-motor cortex inhibition during a reaction time task.
Outcome measures
The primary outcome measure of Experiment 1 will be change in MEP peak-to-peak amplitude between patients and healthy volunteers at rest and in two motor conditions. In Experiment 2, the primary outcome measure will be the location of the TMS coil for optimizing inhibition from leg premotor cortex to motor cortex compared to the coil location from arm premotor cortex to motor cortex. Finally, in Experiment 3, the primary outcome measure will be the change in reaction time from baseline to the test condition with transient TMS-induced interruption in premotor cortex function.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years
- Presence of FHD, specifically writer's cramp
- Age over 18 years
- Absence of dystonia or other neurologic condition
Key exclusion criteria (9 listed)
- Concurrent medical, surgical, neurologic or psychiatric condition
- Taking medications which include antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
- Received botulinum toxin injection within 3 months of starting the protocol
- Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
- History of seizure disorder
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 14509648Hallett M. Dystonia: abnormal movements result from loss of inhibition. Adv Neurol. 2004;94:1-9. No abstract available.
- Background: PubMed 14509661Bressman SB. Dystonia genotypes, phenotypes, and classification. Adv Neurol. 2004;94:101-7. No abstract available.
- Background: PubMed 9646753Chen R, Hallett M. Focal dystonia and repetitive motion disorders. Clin Orthop Relat Res. 1998 Jun;(351):102-6.
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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 Focal Dystonia, 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 6 inclusion and 9 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 NCT00309010, 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.