Focal Hand DystoniaNCT00325091
Long-Term Motor Learning in Focal Hand Dystonia
An observational study of Focal Hand Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine the effects of long-term practice of repeated finger movements in people with focal hand dystonia, as compared with healthy volunteers. Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focal Hand Dystonia
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2006to 6 Jan 2014
- 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
- Healthy volunteers:
- Age 18 years and older
- Right-hand dominant (Edinburgh Handedness Quotient greater than 60)
- Able to provide consent for the protocol
- Patients:
- Age 18 years and older
Show all 9Show fewer
- Right hand dominant (Edinburgh Handedness Quotient greater than 60)
- Idiopathic focal hand dystonia in right hand
- Able to provide consent for the protocol
Who cannot join
- Subjects with other medical, surgical, neurologic or psychiatric conditions
- If participants are taking certain centrally acting medications (like antidepressants, anxiolytics/neuroleptics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines) may not be eligible to participate in this study.
- The presence of a cardiac pacemaker, an implanted medical pump, a metal plate or metal object in skull or eye is contraindications for TMS application.
- Patients with seizure disorder or epilepsy
- Subjects without the capacity to give informed consent
- If participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehension
Show all 13Show fewer
- Patients:
- Subjects with any abnormal findings on neurological examination (except right hand), and general physical examination
- Secondary hand dystonia
- Healthy volunteers:
- Subjects with any abnormal findings on neurological examination and general physical examination
- Subjects who have learned to play the piano or any other keyboard instrument in the past.
- Subjects who have jobs or are involved in daily activities that demand skilled, fine-finger movements
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 the effects of long-term practice of repeated finger movements in people with focal hand dystonia, as compared with healthy volunteers. Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved.
Right-handed healthy volunteers and patients with focal hand dystonia of the right hand 18 years of age and older may be eligible for this study. Candidates are screened with a medical history and neurological and physical examination.
Read more
Participants are trained daily for 11 days (excluding weekends) at the NIH and are asked to continue with daily 15 minutes of practice over a 12-week period to perform sequential finger movement task (key presses) with their left hand. They practice initially at NIH and then at home. At each clinic visit, their learning of the motor skill is assessed by recording their performance of 20 consecutive trials of the eight sequences (a total of 160 key presses) in the task.
To evaluate long-term motor learning of the sequential movements, participants are asked to do different task tests at Day 2, Week 4 and Week 12. Brain wave activity, and brain excitability are also measured during these days. In one task, they see a random series of letters on a screen during the sequential finger movements and are asked to say the number of times they see a specific letter. In another task, they are asked to focus on each specific movement while performing the sequential finger movements. During each visit, they are questioned and evaluated for the development of any abnormal movements that may be suggestive of early dystonia.
All participants have an electroencephalogram (EEG) and transcranial magnetic stimulation (TMS) at Day 1, and Day 2 and at Week 4 and Week 12 to evaluate brain activity. For the EEG, electrodes are placed on the subject's scalp and the electrical activity of the brain is recorded while the subject performs the sequence of finger movements. For 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. The effect of TMS on the muscles is detected with small electrodes taped to the skin of the subject's arms or legs.
...
Read the detailed description
OBJECTIVE:
The overall goal of this proposal is to provide new insights into long-term motor learning by studying patients with focal hand dystonia (FHD) and healthy controls. Long-term motor learning has never been studied in FHD patients. Our central hypothesis is that dystonia is caused by abnormal long-term motor learning. Specifically, the aims of this study are:
- To show that FHD patients have abnormal motor learning, and in particular, have slower motor skill acquisition compared to healthy controls.
- To show that FHD patients have difficulty in performing newly acquired motor skills automatically.
- To study brain dynamics (i.e. cortico-cortical connectivity and motor cortex excitability) in FHD patients and healthy controls while learning a sequence of finger movements over a 3-month period of time.
STUDY POPULATION:
We will follow 10 patients with FHD affecting their dominant hand and 10 healthy volunteers.
DESIGN:
We have devised this case-control experimental study to evaluate the long-term learning of sequential finger movements in FHD patients and healthy controls. We will study FHD patients and healthy volunteers for 12 weeks as they learn a 4 finger sequence of eight key presses with their left hand using a metronome to mark the rhythm. All subjects will be right-handed and age-matched. They will be asked to practice this sequence of 8 key presses daily for 30 minutes for the first week and then for 15 minutes for the remainder of the study. For the first 3 weeks of the study, subjects will come to the Clinical Center (CC) 10 times at regular intervals based on their availability. They will practice daily at the CC or at home during this period. They will then come to the CC every 2 weeks (plus or minus 3 days) for the remainder of the study while practicing daily for 15 minutes. At each visit, learning will be assessed by measuring the sequence error rates (SER) and variability in the interval between key presses. All subjects will be asked to keep a log of daily practice during the 12 weeks. At each visit patients will be carefully questioned and evaluated for the development of abnormal movement patterns suggestive of early dystonia.
OUTCOME MEASURES:
The primary outcome of this study will be to measure the SER at baseline, week 4 and week 12 using 20 consecutive trials of the 8 sequences. We will measure multiple secondary outcomes: (a) variability in the interval between key presses; (b) automaticity of the movement evaluated by a dual task; (c) constrained action evaluated by a thinking task; (d) transcranial magnetic stimulation (TMS) and electroencephalography (EEG) studies to explore changes in brain physiology.
- Conditions
- Focal Hand Dystonia
- Keywords
- Writer's Cramp, Electroencephalogram (EEG), Transcranial Magnetic Stimulation (TMS), Fine Motor Skills, Focal Hand Dystonia, Writer Cramp, Healthy Volunteer, HV
- Medical subject headings
- Dystonia, Focal, Task-Specific, Dystonic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study start9 May 2006
- Study completion6 Jan 2014
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 Hand 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
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325091
- Sponsor's protocol ID
- 060161
- Other IDs
- 06-N-0161
- Status last verified
- 6 Jan 2014
- First submitted
- 11 May 2006
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Agostino R, Berardelli A, Formica A, Accornero N, Manfredi M. Sequential arm movements in patients with Parkinson's disease, Huntington's disease and dystonia. Brain. 1992 Oct;115 ( Pt 5):1481-95. doi: 10.1093/brain/115.5.1481.
PubMed 1422799Andres FG, Mima T, Schulman AE, Dichgans J, Hallett M, Gerloff C. Functional coupling of human cortical sensorimotor areas during bimanual skill acquisition. Brain. 1999 May;122 ( Pt 5):855-70. doi: 10.1093/brain/122.5.855.
PubMed 10355671Byl NN, Merzenich MM, Jenkins WM. A primate genesis model of focal dystonia and repetitive strain injury: I. Learning-induced dedifferentiation of the representation of the hand in the primary somatosensory cortex in adult monkeys. Neurology. 1996 Aug;47(2):508-20. doi: 10.1212/wnl.47.2.508.
PubMed 8757029
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Motor Learning in Focal Hand Dystonia
- ClinicalTrials.gov ID
- NCT00325091
- Acronym / sponsor ID
- 060161
- Conditions
- Focal Hand Dystonia
- Keywords
- Writer's Cramp, Electroencephalogram (EEG), Transcranial Magnetic Stimulation (TMS), Fine Motor Skills, Focal Hand Dystonia, Writer Cramp, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 May 2006
- Study completion
- 6 Jan 2014
- First posted
- 12 May 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 the effects of long-term practice of repeated finger movements in people with focal hand dystonia, as compared with healthy volunteers. Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved.
Right-handed healthy volunteers and patients with focal hand dystonia of the right hand 18 years of age and older may be eligible for this study. Candidates are screened with a medical history and neurological and physical examination.
Participants are trained daily for 11 days (excluding weekends) at the NIH and are asked to continue with daily 15 minutes of practice over a 12-week period to perform sequential finger movement task (key presses) with their left hand. They practice initially at NIH and then at home. At each clinic visit, their learning of the motor skill is assessed by recording their performance of 20 consecutive trials of the eight sequences (a total of 160 key presses) in the task.
To evaluate long-term motor learning of the sequential movements, participants are asked to do different task tests at Day 2, Week 4 and Week 12. Brain wave activity, and brain excitability are also measured during these days. In one task, they see a random series of letters on a screen during the sequential finger movements and are asked to say the number of times they see a specific letter. In another task, they are asked to focus on each specific movement while performing the sequential finger movements. During each visit, they are questioned and evaluated for the development of any abnormal movements that may be suggestive of early dystonia.
All participants have an electroencephalogram (EEG) and transcranial magnetic stimulation (TMS) at Day 1, and Day 2 and at Week 4 and Week 12 to evaluate brain activity. For the EEG, electrodes are placed on the subject's scalp and the electrical activity of the brain is recorded while the subject performs the sequence of finger movements. For 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. The effect of TMS on the muscles is detected with small electrodes taped to the skin of the subject's arms or legs.
...
Detailed description
OBJECTIVE:
The overall goal of this proposal is to provide new insights into long-term motor learning by studying patients with focal hand dystonia (FHD) and healthy controls. Long-term motor learning has never been studied in FHD patients. Our central hypothesis is that dystonia is caused by abnormal long-term motor learning. Specifically, the aims of this study are:
- To show that FHD patients have abnormal motor learning, and in particular, have slower motor skill acquisition compared to healthy controls.
- To show that FHD patients have difficulty in performing newly acquired motor skills automatically.
- To study brain dynamics (i.e. cortico-cortical connectivity and motor cortex excitability) in FHD patients and healthy controls while learning a sequence of finger movements over a 3-month period of time.
STUDY POPULATION:
We will follow 10 patients with FHD affecting their dominant hand and 10 healthy volunteers.
DESIGN:
We have devised this case-control experimental study to evaluate the long-term learning of sequential finger movements in FHD patients and healthy controls. We will study FHD patients and healthy volunteers for 12 weeks as they learn a 4 finger sequence of eight key presses with their left hand using a metronome to mark the rhythm. All subjects will be right-handed and age-matched. They will be asked to practice this sequence of 8 key presses daily for 30 minutes for the first week and then for 15 minutes for the remainder of the study. For the first 3 weeks of the study, subjects will come to the Clinical Center (CC) 10 times at regular intervals based on their availability. They will practice daily at the CC or at home during this period. They will then come to the CC every 2 weeks (plus or minus 3 days) for the remainder of the study while practicing daily for 15 minutes. At each visit, learning will be assessed by measuring the sequence error rates (SER) and variability in the interval between key presses. All subjects will be asked to keep a log of daily practice during the 12 weeks. At each visit patients will be carefully questioned and evaluated for the development of abnormal movement patterns suggestive of early dystonia.
OUTCOME MEASURES:
The primary outcome of this study will be to measure the SER at baseline, week 4 and week 12 using 20 consecutive trials of the 8 sequences. We will measure multiple secondary outcomes: (a) variability in the interval between key presses; (b) automaticity of the movement evaluated by a dual task; (c) constrained action evaluated by a thinking task; (d) transcranial magnetic stimulation (TMS) and electroencephalography (EEG) studies to explore changes in brain physiology.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years and older
- Right-hand dominant (Edinburgh Handedness Quotient greater than 60)
- Able to provide consent for the protocol
- Age 18 years and older
- Right hand dominant (Edinburgh Handedness Quotient greater than 60)
Key exclusion criteria (13 listed)
- Subjects with other medical, surgical, neurologic or psychiatric conditions
- If participants are taking certain centrally acting medications (like antidepressants, anxiolytics/neuroleptics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines) may not be eligible to participate in this study.
- The presence of a cardiac pacemaker, an implanted medical pump, a metal plate or metal object in skull or eye is contraindications for TMS application.
- Patients with seizure disorder or epilepsy
- Subjects without the capacity to give informed consent
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 17 Dec 2019.
- Background: PubMed 1422799Agostino R, Berardelli A, Formica A, Accornero N, Manfredi M. Sequential arm movements in patients with Parkinson's disease, Huntington's disease and dystonia. Brain. 1992 Oct;115 ( Pt 5):1481-95. doi: 10.1093/brain/115.5.1481.
- Background: PubMed 10355671Andres FG, Mima T, Schulman AE, Dichgans J, Hallett M, Gerloff C. Functional coupling of human cortical sensorimotor areas during bimanual skill acquisition. Brain. 1999 May;122 ( Pt 5):855-70. doi: 10.1093/brain/122.5.855.
- Background: PubMed 8757029Byl NN, Merzenich MM, Jenkins WM. A primate genesis model of focal dystonia and repetitive strain injury: I. Learning-induced dedifferentiation of the representation of the hand in the primary somatosensory cortex in adult monkeys. Neurology. 1996 Aug;47(2):508-20. doi: 10.1212/wnl.47.2.508.
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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.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Hand 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 9 inclusion and 13 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 17 Dec 2019. 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 NCT00325091, 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 17 Dec 2019.