Plasticity in Cervical Dystonia
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic, Women's Studies |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2006 |
| End Date: | May 2008 |
This study will identify changes that occur in the part of the brain that controls hand
movements in patients with cervical (neck) dystonia. 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. The study will
compare findings in healthy volunteers and patients with cervical dystonia to learn more
about the condition.
Healthy volunteers and patients with cervical dystonia 18 years of age and older may be
eligible to participate. Candidates are screened with a medical history and physical
examination. Participants undergo the following tests:
Somatosensory evoked potentials (Visits 1 and 2)
This test examines how sensory information travels from the nerves to the spinal cord and
brain. An electrode placed on an arm or leg delivers a small electrical stimulus and
additional electrodes placed on the scalp, neck and over the collarbone record how the
impulse from the stimulus travels over the nerve pathways.
Transcranial Magnetic Stimulation (Visits 2, 3 and 4)
This procedure maps brain function. A wire coil is held on the scalp. A brief electrical
current passes through the coil, creating a magnetic pulse that stimulates the brain. 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.
Nerve conduction studies (Visits 2, 3 and 4)
This test measures how fast nerves conduct electrical impulses and the strength of the
connection between the nerve and the muscle. Nerves are stimulated through small wire
electrodes attached to the skin and the response is recorded and analyzed.
Surface electromyography (Visits 2, 3 and 4)
Electrodes are placed on the front and back of the neck muscles to measure the electrical
activity of the muscles.
movements in patients with cervical (neck) dystonia. 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. The study will
compare findings in healthy volunteers and patients with cervical dystonia to learn more
about the condition.
Healthy volunteers and patients with cervical dystonia 18 years of age and older may be
eligible to participate. Candidates are screened with a medical history and physical
examination. Participants undergo the following tests:
Somatosensory evoked potentials (Visits 1 and 2)
This test examines how sensory information travels from the nerves to the spinal cord and
brain. An electrode placed on an arm or leg delivers a small electrical stimulus and
additional electrodes placed on the scalp, neck and over the collarbone record how the
impulse from the stimulus travels over the nerve pathways.
Transcranial Magnetic Stimulation (Visits 2, 3 and 4)
This procedure maps brain function. A wire coil is held on the scalp. A brief electrical
current passes through the coil, creating a magnetic pulse that stimulates the brain. 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.
Nerve conduction studies (Visits 2, 3 and 4)
This test measures how fast nerves conduct electrical impulses and the strength of the
connection between the nerve and the muscle. Nerves are stimulated through small wire
electrodes attached to the skin and the response is recorded and analyzed.
Surface electromyography (Visits 2, 3 and 4)
Electrodes are placed on the front and back of the neck muscles to measure the electrical
activity of the muscles.
Objectives
The main objective of this proposal is to evaluate plasticity in patients with cervical
dystonia. Neither abnormal Hebbian nor non-Hebbian plasticity has been studied for cervical
dystonia.
Our specific objectives are to show that:
1. In patients with cervical dystonia, Hebbian plasticity can be induced by using paired
associative stimulation (PAS) of the dystonic sternocleidomastoid muscle (SCM) muscle
and will be enhanced compared to that of healthy subjects.
2. In patients with cervical dystonia, non-Hebbian plasticity can be induced by using
transcutaneous electrical nerve stimulation (TENS) of the dystonic SCM muscle and will
be enhanced compared to that of healthy subjects.
3. In patients with cervical dystonia, Hebbian and non-Hebbian plasticity can be induced
by dual stimulation (DS) of the dystonic SCM muscle, this effect will be greater than
PAS or TENS alone, and it will be enhanced compared to that of healthy subjects.
Study Population
We will study 22 patients with cervical dystonia and 22 healthy subjects for a total of 44
subjects.
Study Design
Subjects will participate in 4 different sessions:
Visit 1: clinical screening (1 hour) and sensory evoked potential (SEP) assessment (2 hours,
total of 3 hours).
Visit 2: PAS session of the target muscle and monitoring of cortical excitability before
(T0), immediately after (T1), 45 minutes after (T2) and 90 minutes after T(3) (Total of 4
hours).
Visit 3: TENS session of the target muscle and monitoring of cortical excitability before
(T0), immediately after (T1), 45 minutes after (T2) and 90 minutes after T(3) (Total of 4
hours).
Visit 4: DS session of the target and monitoring of cortical excitability before (T0),
immediately after (T1), 45 minutes after (T2) and 90 minutes after T(3) (Total of 4 hours).
Outcome Measures
The electrophysiological effects of the interventions will be assessed by the size of motor
evoked potentials (MEP), resting and active motor threshold (RMT and AMT), and a
transcranial magnetic stimulation (TMS) input-output curve. The activity of intracortical
interneurons mediating long intracortical inhibition (LICI) will be assessed by paired-pulse
TMS. The effect of afferent input on intracortical processes (long afferent inhibition, LAI)
will be assessed by stimulating the skin overlying the sternocleidomastoid muscle (SCM).
The main objective of this proposal is to evaluate plasticity in patients with cervical
dystonia. Neither abnormal Hebbian nor non-Hebbian plasticity has been studied for cervical
dystonia.
Our specific objectives are to show that:
1. In patients with cervical dystonia, Hebbian plasticity can be induced by using paired
associative stimulation (PAS) of the dystonic sternocleidomastoid muscle (SCM) muscle
and will be enhanced compared to that of healthy subjects.
2. In patients with cervical dystonia, non-Hebbian plasticity can be induced by using
transcutaneous electrical nerve stimulation (TENS) of the dystonic SCM muscle and will
be enhanced compared to that of healthy subjects.
3. In patients with cervical dystonia, Hebbian and non-Hebbian plasticity can be induced
by dual stimulation (DS) of the dystonic SCM muscle, this effect will be greater than
PAS or TENS alone, and it will be enhanced compared to that of healthy subjects.
Study Population
We will study 22 patients with cervical dystonia and 22 healthy subjects for a total of 44
subjects.
Study Design
Subjects will participate in 4 different sessions:
Visit 1: clinical screening (1 hour) and sensory evoked potential (SEP) assessment (2 hours,
total of 3 hours).
Visit 2: PAS session of the target muscle and monitoring of cortical excitability before
(T0), immediately after (T1), 45 minutes after (T2) and 90 minutes after T(3) (Total of 4
hours).
Visit 3: TENS session of the target muscle and monitoring of cortical excitability before
(T0), immediately after (T1), 45 minutes after (T2) and 90 minutes after T(3) (Total of 4
hours).
Visit 4: DS session of the target and monitoring of cortical excitability before (T0),
immediately after (T1), 45 minutes after (T2) and 90 minutes after T(3) (Total of 4 hours).
Outcome Measures
The electrophysiological effects of the interventions will be assessed by the size of motor
evoked potentials (MEP), resting and active motor threshold (RMT and AMT), and a
transcranial magnetic stimulation (TMS) input-output curve. The activity of intracortical
interneurons mediating long intracortical inhibition (LICI) will be assessed by paired-pulse
TMS. The effect of afferent input on intracortical processes (long afferent inhibition, LAI)
will be assessed by stimulating the skin overlying the sternocleidomastoid muscle (SCM).
- INCLUSION CRITERIA:
- Healthy volunteers (aged 18 or older) who are willing to participate
- Patients (aged 18 and older) with idiopathic cervical dystonia that show a clear
asymmetric involvement of the SCM muscles with lateral rotation of the head in the
coronal or longitudinal plane
EXCLUSION CRITERIA:
- Subjects with additional significant neurological disorder, current use or a history
of alcohol or drug abuse, psychiatric disorder requiring hospitalization or prolonged
treatment such as substance abuse addiction, head injury with loss of consciousness,
epilepsy.
- Subjects with significant hearing loss
- Subjects receiving drugs with significant action on the central nervous system
- Subjects who have been treated with botulinum toxin injections less than 3 months
prior to their participation in the study
- Subjects who are taking any oral medication for dystonia at the time of the study
The following exclusion criteria are due to the use of transcranial magnetic stimulation:
- Subjects with cardiac pacemakers, implanted medication pumps
- Subjects with eye, blood vessel, cochlear, or eye implants
- Subjects with increased intracranial pressure as evaluated by clinical means
- Subjects with metal in the cranium
- Subjects with dental braces (but dental fillings are acceptable), metal fragments
from occupational exposure or surgical clips in or near the brain
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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