Effects of Botulinum Toxin in Cervical Dystonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Henry Ford Health System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Allergan
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01056861
First received: January 25, 2010
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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 Intervention
Torticollis
Cervical Dystonia
Drug: Botulinum Toxin A

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Botulinum on the Afferent Input Modulation of Neuronal Circuits Involved in Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Evidence of Cortical organizational changes with botulinum toxin treatment in patients with torticollis utilizing magnetoencephalography [ Time Frame: two to eight weeks following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tsui Torticollis Rating scale [ Time Frame: Two-eight weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056861

Contacts
Contact: Naganand Sripathi, MD 3139167370 nsripat2@hfhs.org
Contact: Susan M Bowyer, PhD 3135857840 sbowyer1@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Naganand Sripathi, MD    313-916-7370    nsripat2@hfhs.org   
Contact: Kavita M Grover, MD    3139167370    kgrover1@hfhs.org   
Principal Investigator: Naganad Sripathi, MD         
Sponsors and Collaborators
Henry Ford Health System
Allergan
Investigators
Principal Investigator: Naganand Sripathi, MD Henry Ford Health System
  More Information

No publications provided

Responsible Party: Naganand Sripathi, Henry Ford Hospital
ClinicalTrials.gov Identifier: NCT01056861     History of Changes
Other Study ID Numbers: 5307, 08-0124
Study First Received: January 25, 2010
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Botulinum Toxins, Type A
Botulinum Toxins
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014