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Effects of Botulinum Toxin in Cervical Dystonia
This study has been completed.
Sponsor:
Henry Ford Health System
Collaborator:
Allergan
Information provided by (Responsible Party):
Naganad Sripathi, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01056861
First received: January 25, 2010
Last updated: April 16, 2015
Last verified: April 2015
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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 Naganad Sripathi, 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 ]
Secondary Outcome Measures:
- Tsui Torticollis Rating scale [ Time Frame: Two-eight weeks ]
| Enrollment: | 7 |
| Study Start Date: | January 2010 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | July 2014 (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 (Adult, Senior) |
| 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
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01056861
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056861
Locations
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
Sponsors and Collaborators
Henry Ford Health System
Allergan
Investigators
| Principal Investigator: | Naganand Sripathi, MD | Henry Ford Health System |
More Information
| 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 ) |
| Study First Received: | January 25, 2010 |
| Last Updated: | April 16, 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 |
abobotulinumtoxinA onabotulinumtoxinA incobotulinumtoxinA 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 |
ClinicalTrials.gov processed this record on June 28, 2017