Writer's Cramp Clinical Trial
Official title:
Corticomotor Plasticity as a Biomarker for Functional Improvement After Botulinium Treatment in Writer's Cramp
Writer's cramp (WC) is a form of focal dystonia, a movement disorder characterized by sustained or intermittent muscle contractions causing abnormal, often repetitive movements, postures, or both. It typically manifests while writing, making handwriting impossible in the most severe cases. Treatment can be difficult, but one effective and well-tolerated treatment consists in local muscle injections with botulinum toxin. Although clinical improvement seems to be related to focal muscle chemodenervation, central plasticity changes may occur. The main aim of the study is to characterize and quantify the changes in intrinsic hand muscle cortical representations at rest and during isometric contractions of the finger muscles before and after treatment with botulinum toxin and the changes in sensorimotor integration in patients with writer's cramp.
Fifteen WC patients will be enrolled in the study. A newly developed neuronavigated and
robotized Transcranial Magnetic Stimulation (TMS) mapping approach will be used. It will
generate a linear mediolateral excitability profile for two intrinsic hand muscle based on
the mean Motor Evoked Potentials (MEPs) amplitude at each stimulation site. Changes in
excitability profiles will reflect spatial reorganization of cortical motor output maps of
the hand muscles. To measure afferent inhibition, the same mapping procedure will be repeated
with a brief peripheral electrical stimulation prior the TMS pulse. These Short Afferent
Inhibition (SAI) profiles will reflect the influence of the primary sensory cortex over the
motor cortex. Finally, the stimulation grid will be translated to the primary somatosensory
cortex and a paired pulse TMS paradigm will be applied just after a digital nerve
stimulation. It will generate afferent signal processing profiles based on subjective
perception for the index finger and the little finger. Participants will be tested before the
botulinum toxin injections and at three different time points after the injections (7 days, 1
month and 3 months after). Botulinum toxin injections will be performed using ultrasound
guide together with electromyography/nerve stimulation into the clinical affected hand
muscles. Muscle selection for injections will be based on clinical criteria of postural
deviation of the hand and fingers and responsible muscle forces. The dose will be chosen
according to published clinical recommendation concerning starting dose for WC after the
clinical examination, usually between 5 and 10 units of Xeomin® both for flexor and extensor
hand/forearm muscles.
To precisely assess treatment efficacy, the Writer's Cramp Rating Scale (WCRS) as well as
computer-based hand writing analyses and standard sensorimotor tests of hand functions (the
Nine Holes Peg Test, a tapping test and a tactile spatial acuity task) will be performed
before the injections and at each follow up session.
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