Effects of Botulinum Toxin in Cervical Dystonia



Status:Completed
Conditions:Neurology, Orthopedic, Women's Studies
Therapuetic Areas:Neurology, Orthopedics / Podiatry, Reproductive
Healthy:No
Age Range:18 - 90
Updated:4/13/2015
Start Date:January 2010
End Date:October 2012
Contact:Naganand Sripathi, MD
Email:nsripat2@hfhs.org
Phone:3139167370

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Effects of Botulinum on the Afferent Input Modulation of Neuronal Circuits Involved in Cervical Dystonia

Botulinum toxin injection in the contracting muscles has proven to be a safe and effective
method of relieving pain and lessening dystonic posturing. The current hypothesis is that
botulinum toxin works on altering sensory input in the central nervous system in addition to
its effects on the neuromuscular junction.

Magnetoencephalography (MEG)of brain has been used in dystonia such as writer's cramp and
musician's hand dystonia. However, no study has investigated the correlation of central
signal changes via magnetoencephalography before and after treatment with botulinum in
torticollis patients. Prior studies using somatosensory potentials indicated the
possibility of differential activation of precentral cortex in patients with cervical
dystonia. Cervical dystonia may result from a disorder of both cortical excitability and
intracortical inhibition. The investigators hypothesis is that botulinum injection
modulates central inhibition which improves clinical outcome for torticollis.

This study of MEG neuro-imagery will increase the understanding of the central pathway
involvement in the efficacy of botulinum toxin treatment for torticollis. Cervical dystonia
(spasmodic torticollis) patients will be selected from the Neurology clinic. Subjects will
range in age from 18 years old through 90 years old. Subjects are expected to be ambulatory
and independent. Patients are generally expected to be in good health. Exclusion criteria
include significant intracranial metal (typically fixed dental bridges or braces) generating
significant magnetic artifact, medical instability, pregnancy, and certain other factors
such as severe head tremors that would produce magnetic artifact. Clinical states of
torticollis patients will be assessed by using Tsui scale. Every torticollis patient will
have magnetoencephalography on the day of botulinum treatment beforehand and approximately
2-8 weeks after botulinum treatment. We will compare the results of magnetoencephalography
between control subject and torticollis patient before botulinum treatment aiming to find
any difference between the two populations. We also compare the results of
magnetoencephalography in individual torticollis patient before and after botulinum
treatment, aiming to detect the changes between these two conditions in the same individual
and possibly between the average of data from each condition before and after botulinum
treatment.

Inclusion Criteria:

- male or female subjects 18 years to 90 years

- females who are child bearing potential, with negative pregnancy testing, who are
willing to use reliable form of contraception during the study

- subjects meeting the criteria for torticollis

Exclusion Criteria:

- intracranial metal objects generating significant magnetic artifact

- females who are pregnant, planning pregnancy, unable to use contraception

- mental instability

- any medical condition that may put the subject at increased risk with exposure to
botulinum toxin, allergy or sensitivity

- significant head tremor
We found this trial at
1
site
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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