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

History of Changes

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:

Genetics Home Reference related topics: dopa-responsive dystonia early-onset primary dystonia

MedlinePlus related topics: Dystonia

Genetic and Rare Diseases Information Center resources: Cervical Dystonia

U.S. FDA Resources

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:


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

ClinicalTrials.gov processed this record on March 03, 2015

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