COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Effects of Botulinum Toxin in Cervical Dystonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056861
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : April 17, 2015
Information provided by (Responsible Party):
Naganad Sripathi, Henry Ford Health System

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.

Layout table for study 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

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

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

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056861

Layout table for location information
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Layout table for investigator information
Principal Investigator: Naganand Sripathi, MD Henry Ford Health System
Layout table for additonal information
Responsible Party: Naganad Sripathi, Senior Staff Neurologist, Henry Ford Health System Identifier: NCT01056861    
Other Study ID Numbers: 5307
08-0124 ( Other Grant/Funding Number: Allergan1 )
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015
Keywords provided by Naganad Sripathi, Henry Ford Health System:
cervical dystonia
Botulinum toxin
cortical organizational changes detected by MEG after botulinum toxin in patients with torticollis, correlating with improvement in the symptoms
Additional relevant MeSH terms:
Layout table for MeSH terms
Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
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