Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325091
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-05-11
Brief Title:
Long-Term Motor Learning in Focal Hand Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Long-Term Motor Learning in Focal Hand Dystonia
Status:
COMPLETED
Status Verified Date:
2014-01-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 subjects 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 subjects 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 subjects arms or legs
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 subjects 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 subjects 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 subjects 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
1 To show that FHD patients have abnormal motor learning and in particular have slower motor skill acquisition compared to healthy controls
2 To show that FHD patients have difficulty in performing newly acquired motor skills automatically
3 To study brain dynamics ie 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
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
1 To show that FHD patients have abnormal motor learning and in particular have slower motor skill acquisition compared to healthy controls
2 To show that FHD patients have difficulty in performing newly acquired motor skills automatically
3 To study brain dynamics ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-N-0161 | None | None | None |