Effects of Botulinum Toxin in Cervical Dystonia

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment
Torticollis; Cervical Dystonia	Drug: Botulinum Toxin A

Detailed Description:

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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	7 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	Effects of Botulinum on the Afferent Input Modulation of Neuronal Circuits Involved in Cervical Dystonia
Study Start Date :	January 2010
Actual Primary Completion Date :	July 2014
Actual Study Completion Date :	July 2014

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Cervical dystonia (torticollis); Subjects meeting the criteria fot torticollis who are receiving botulinum toxin injections.	Drug: Botulinum Toxin A; Not exceeding a total dose of 400 units, once every three months.; Other Name: Botox, Botulinum toxin A
Control; age matched controls with out cervical dystonia (torticollis)	Drug: Botulinum Toxin A; Not exceeding a total dose of 400 units, once every three months.; Other Name: Botox, Botulinum toxin A

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Evidence of Cortical organizational changes with botulinum toxin treatment in patients with torticollis utilizing magnetoencephalography [ Time Frame: two to eight weeks following treatment ]

Secondary Outcome Measures :

1. Tsui Torticollis Rating scale [ Time Frame: Two-eight weeks ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects meeting the criteria for cervical dystonia (torticollis) who are receiving botulinum toxin injections in the Neurology Clinic

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202

Sponsors and Collaborators

Henry Ford Health System

Allergan

Investigators

Principal Investigator:	Naganand Sripathi, MD	Henry Ford Health System

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Naganad Sripathi, Senior Staff Neurologist, Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT01056861 History of Changes
Other Study ID Numbers:	5307; 08-0124 ( Other Grant/Funding Number: Allergan1 )
First Posted:	January 26, 2010
Last Update Posted:	April 17, 2015
Last Verified:	April 2015

Keywords provided by Naganad Sripathi, Henry Ford Health System:

cervical dystonia; torticollis; Botulinum toxin	magnetoencephalography; MEG; cortical organizational changes detected by MEG after botulinum toxin in patients with torticollis, correlating with improvement in the symptoms

Additional relevant MeSH terms:

Dystonia; Dystonic Disorders; Torticollis; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Botulinum Toxins; Botulinum Toxins, Type A	onabotulinumtoxinA; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents