Cervical Dystonia Clinical Trial
Official title:
Plasticity in Cervical Dystonia
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.
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).
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