Effects of Botulinum Toxin in Cervical Dystonia

April 16, 2015 updated by: Naganad Sripathi, Henry Ford Health System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Botox, Botulinum toxin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of Cortical organizational changes with botulinum toxin treatment in patients with torticollis utilizing magnetoencephalography
Time Frame: two to eight weeks following treatment
two to eight weeks following treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Tsui Torticollis Rating scale
Time Frame: Two-eight weeks
Two-eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

Allergan

Investigators

  • Principal Investigator: Naganand Sripathi, MD, Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5307
  • 08-0124 (Other Grant/Funding Number: Allergan1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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