Effects of Botulinum Toxin in Cervical Dystonia

NCT01056861 | Completed

• 2 other identifiers: 530708-0124
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Torticollis; Cervical Dystonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evidence of Cortical organizational changes with botulinum toxin treatment in patients with torticollis utilizing magnetoencephalography

  two to eight weeks following treatment

Secondary Outcomes (1)

• Tsui Torticollis Rating scale

  Two-eight weeks

Study Arms (2)

Cervical dystonia (torticollis)

Subjects meeting the criteria fot torticollis who are receiving botulinum toxin injections.

Drug: Botulinum Toxin A

Control

age matched controls with out cervical dystonia (torticollis)

Drug: Botulinum Toxin A

Interventions

Botulinum Toxin A DRUG

Not exceeding a total dose of 400 units, once every three months.

Also known as: Botox, Botulinum toxin A

Cervical dystonia (torticollis); Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• Allergan: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Naganand Sripathi, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Neurologist

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

US (1)