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Effects of Botulinum Toxin in Cervical Dystonia

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ClinicalTrials.gov Identifier: NCT01056861
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : April 17, 2015
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Naganad Sripathi, Henry Ford Health System

January 25, 2010
January 26, 2010
April 17, 2015
January 2010
July 2014   (Final data collection date for primary outcome measure)
Evidence of Cortical organizational changes with botulinum toxin treatment in patients with torticollis utilizing magnetoencephalography [ Time Frame: two to eight weeks following treatment ]
Same as current
Complete list of historical versions of study NCT01056861 on ClinicalTrials.gov Archive Site
Tsui Torticollis Rating scale [ Time Frame: Two-eight weeks ]
Same as current
Not Provided
Not Provided
 
Effects of Botulinum Toxin in Cervical Dystonia
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Subjects meeting the criteria for cervical dystonia (torticollis) who are receiving botulinum toxin injections in the Neurology Clinic
  • Torticollis
  • Cervical Dystonia
Drug: Botulinum Toxin A
Not exceeding a total dose of 400 units, once every three months.
Other Name: Botox, Botulinum toxin A
  • Cervical dystonia (torticollis)
    Subjects meeting the criteria fot torticollis who are receiving botulinum toxin injections.
    Intervention: Drug: Botulinum Toxin A
  • Control
    age matched controls with out cervical dystonia (torticollis)
    Intervention: Drug: Botulinum Toxin A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
20
July 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01056861
5307
08-0124 ( Other Grant/Funding Number: Allergan1 )
No
Not Provided
Not Provided
Naganad Sripathi, Henry Ford Health System
Henry Ford Health System
Allergan
Principal Investigator: Naganand Sripathi, MD Henry Ford Health System
Henry Ford Health System
April 2015