Focal Hand Dystonia Clinical Trial
Official title:
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.
...
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 (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.
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