Transcranial Electrical Polarization to Treat Focal Hand Dystonia
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2005 |
| End Date: | May 2010 |
Placebo Controlled Study of the Therapeutic Effect of the Transcranial Electrical Polarization in Patients With Focal Hand Dystonia
This study will evaluate the effect of transcranial electrical polarization (TEP), also
called direct current (DC) stimulation, on focal hand dystonia in people with writer's
cramp. In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or
abnormal postures. Focal dystonia involves just one part of the body, such as the hand, neck
or face. When people with focal hand dystonia make small and repeated movements with their
hands, there is extra activity in the part of the brain called the motor cortex. TEP is a
method of brain stimulation that slows down the activity of the nerve cells in the motor
cortex. This study may help researchers develop new ways to treat focal hand dystonia.
People 18 years of age and older with focal hand dystonia may be eligible for this study.
Participants have a neurological examination and are randomly assigned to one of two
treatment groups: TEP or placebo stimulation. The TEP group receives stimulation to the
parts of the brain used for hand movement, and the placebo group receives sham stimulation,
which does not affect any area of the brain. There are three TEP/placebo sessions over a
period of 7 to 10 days. The first session may last up to 2-1/2 hours; the other two sessions
last 1-2 hours.
For TEP, sponge electrodes are placed on the scalp and an electrical current is passed
through the scalp and skull to the outer part of brain. Before and after each session,
participants have a neurological examination, including an evaluation of the rate and
severity of their movement problems. For this assessment, participants do a writing test
while the electrical activity of their hand muscles is recorded using surface
electromyography (EMG). For EMG, small metal disks (electrodes) filled with a conductive gel
are taped to the skin over the muscles being tested.
Patients are followed in the clinic the day after the end of TEP treatment for evaluation of
their movement abilities and the effects of therapy, such as improvement of handwriting.
called direct current (DC) stimulation, on focal hand dystonia in people with writer's
cramp. In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or
abnormal postures. Focal dystonia involves just one part of the body, such as the hand, neck
or face. When people with focal hand dystonia make small and repeated movements with their
hands, there is extra activity in the part of the brain called the motor cortex. TEP is a
method of brain stimulation that slows down the activity of the nerve cells in the motor
cortex. This study may help researchers develop new ways to treat focal hand dystonia.
People 18 years of age and older with focal hand dystonia may be eligible for this study.
Participants have a neurological examination and are randomly assigned to one of two
treatment groups: TEP or placebo stimulation. The TEP group receives stimulation to the
parts of the brain used for hand movement, and the placebo group receives sham stimulation,
which does not affect any area of the brain. There are three TEP/placebo sessions over a
period of 7 to 10 days. The first session may last up to 2-1/2 hours; the other two sessions
last 1-2 hours.
For TEP, sponge electrodes are placed on the scalp and an electrical current is passed
through the scalp and skull to the outer part of brain. Before and after each session,
participants have a neurological examination, including an evaluation of the rate and
severity of their movement problems. For this assessment, participants do a writing test
while the electrical activity of their hand muscles is recorded using surface
electromyography (EMG). For EMG, small metal disks (electrodes) filled with a conductive gel
are taped to the skin over the muscles being tested.
Patients are followed in the clinic the day after the end of TEP treatment for evaluation of
their movement abilities and the effects of therapy, such as improvement of handwriting.
Objective: The treatment of focal hand dystonia (FHD) needs further improvement. A
deficiency of inhibition was demonstrated in patients with writer's cramp. The passage of
weak DC currents across the head, or transcranial electrical polarization (TEP) has been
done for many years with numerous effects described in healthy subjects and mentally
diseased patients. Recently, it has been shown by objective means, in controlled
experiments, that this type of treatment has robust and lasting effects on the excitability
of the motor cortex in healthy humans.
Study population: 40 subjects with focal hand dystonia.
Design: We hypothesize that TEP will have a beneficial effect on hand writing in patients
with FHD because it will decrease the excitability of the motor cortex compensating the
deficiency of inhibition. Specifically, we propose to look at the effect of 2 mA TEP with
cathode position over the hand projection in the contralateral to the affected hand primary
motor cortex. Anodes will be placed over the orbit and mastoid process ipsilateral to the
affected hand (contralateral to the cathode). Over a two-year period, we will enroll 40
patients with FHD and evaluate the acute TEP effects over a period of 1 week (3 TEP
sessions).
Outcome measures: Symptoms will be evaluated by kinematic analysis of the handwriting and
with dystonia scales.
deficiency of inhibition was demonstrated in patients with writer's cramp. The passage of
weak DC currents across the head, or transcranial electrical polarization (TEP) has been
done for many years with numerous effects described in healthy subjects and mentally
diseased patients. Recently, it has been shown by objective means, in controlled
experiments, that this type of treatment has robust and lasting effects on the excitability
of the motor cortex in healthy humans.
Study population: 40 subjects with focal hand dystonia.
Design: We hypothesize that TEP will have a beneficial effect on hand writing in patients
with FHD because it will decrease the excitability of the motor cortex compensating the
deficiency of inhibition. Specifically, we propose to look at the effect of 2 mA TEP with
cathode position over the hand projection in the contralateral to the affected hand primary
motor cortex. Anodes will be placed over the orbit and mastoid process ipsilateral to the
affected hand (contralateral to the cathode). Over a two-year period, we will enroll 40
patients with FHD and evaluate the acute TEP effects over a period of 1 week (3 TEP
sessions).
Outcome measures: Symptoms will be evaluated by kinematic analysis of the handwriting and
with dystonia scales.
- INCLUSION CRITERIA:
- Subjects with focal hand dystonia 18 years old or older will be included.
EXCLUSION CRITERIA:
Exclusion criteria will include the standard exclusions for TEP as well as exclusions
specific to this study.
We will exclude subjects with:
- Any significant medical or psychiatric illness (other than FHD).
- Patients with a positive pregnancy test will be excluded because the effects of TEP
on the fetus is unknown. A urine sample for pregnancy testing will be obtained prior
to the TEP, and on the day of the first TEP session.
- History of epilepsy.
- Concurrent use of neuroleptic agents.
- Any other licit or illicit drugs other that could lower the seizure threshold.
- Metal implants.
- Who have received botulinum toxin injection within 10 weeks of starting the protocol.
- Secondary hand dystonia.
- Mentally impaired patients having no capacity to provide their own consent will be
excluded from the study because such patients may have difficulty performing the
required test.
- 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.
- Unable or unwilling to refrain from alcohol for 24 hours prior to study days.
Patients may continue taking muscle relaxants, artane and other anticholinergic drugs,
L-DOPA and dopamine agonists.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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