Long-Term Motor Learning in Focal Hand Dystonia
|First Received Date ICMJE||May 11, 2006|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||May 9, 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00325091 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Long-Term Motor Learning in Focal Hand Dystonia|
|Official Title ICMJE||Long-Term Motor Learning in Focal Hand Dystonia|
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.
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:
We will follow 10 patients with FHD affecting their dominant hand and 10 healthy volunteers.
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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Focal Hand Dystonia|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||January 6, 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00325091|
|Other Study ID Numbers ICMJE||060161
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 6, 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP