Focal Dystonia Clinical Trial
Official title:
Neurophysiology of Task-Specificity of Focal Hand Dystonia
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04692285 -
Electrophysiological and Neuroimaging Correlates of the Effect of Zolpidem in Patients With Focal Dystonia
|
Phase 1 | |
Completed |
NCT00505323 -
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness
|
Phase 1 | |
Terminated |
NCT03206112 -
Loss of Depotentiation in Focal Dystonia
|
||
Completed |
NCT00025701 -
EEG and EMG Studies of Hand Dystonia
|
N/A | |
Completed |
NCT02334683 -
Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia
|
N/A | |
Completed |
NCT03797638 -
Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects
|
N/A | |
Terminated |
NCT01750346 -
Acetyl Hexapeptide-8 for Blepharospasm
|
Phase 2 | |
Completed |
NCT01738581 -
rTMS and Retraining in Focal Hand Dystonia
|
Phase 1/Phase 2 | |
Terminated |
NCT02106936 -
Depotentiation in People With Focal Hand Dystonia
|
N/A | |
Completed |
NCT00310414 -
fMRI Studies of Task Specificity in Focal Hand Dystonia
|
N/A | |
Completed |
NCT03471923 -
Non-Motor Features of Cervical Dystonia (CD)
|
||
Completed |
NCT00306865 -
Brain Changes in Patients With Focal Hand Dystonia
|
N/A | |
Completed |
NCT00411255 -
Brain Stimulation to Treat Blepharospasm or Meige Syndrome
|
Phase 2 | |
Terminated |
NCT00487383 -
Brain Changes in Blepharospasm
|
||
Recruiting |
NCT05095740 -
Effects of Neuromodulation in Laryngeal Dystonia
|
N/A | |
Completed |
NCT00713414 -
Role of Neurotransmission and Functional CNS Networks in Spasmodic Dysphonia
|
||
Completed |
NCT00942851 -
A Study of Acetyl Hexapeptide-8 (AH8) in Treatment of Blepharospasm
|
Phase 1/Phase 2 | |
Completed |
NCT00118586 -
Neuropathology of Spasmodic Dysphonia
|
||
Completed |
NCT02326818 -
Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity
|
Phase 3 | |
Active, not recruiting |
NCT02911103 -
Deep Brain Stimulation Surgery for Focal Hand Dystonia
|
Phase 1/Phase 2 |