Effects of Botulinum Toxin in Cervical Dystonia
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ClinicalTrials.gov Identifier: NCT01056861 |
Recruitment Status
:
Completed
First Posted
: January 26, 2010
Last Update Posted
: April 17, 2015
|
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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 |
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
|
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
|
- Evidence of Cortical organizational changes with botulinum toxin treatment in patients with torticollis utilizing magnetoencephalography [ Time Frame: two to eight weeks following treatment ]
- Tsui Torticollis Rating scale [ Time Frame: Two-eight weeks ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

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 ClinicalTrials.gov identifier (NCT number): NCT01056861
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 |
Principal Investigator: | Naganand Sripathi, MD | Henry Ford Health System |
Responsible Party: | Naganad Sripathi, Senior Staff Neurologist, Henry Ford Health System |
ClinicalTrials.gov Identifier: | NCT01056861 History of Changes |
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 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 Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases Botulinum Toxins Botulinum Toxins, Type A |
onabotulinumtoxinA abobotulinumtoxinA 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 |