TorticollisNCT01056861
Effects of Botulinum Toxin in Cervical Dystonia
An observational study of Torticollis and Cervical Dystonia, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Torticollis, Cervical Dystonia
- What is being tested?
- Botulinum Toxin A
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects meeting the criteria for cervical dystonia (torticollis) who are receiving botulinum toxin injections in the Neurology Clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Botulinum on the Afferent Input Modulation of Neuronal Circuits Involved in Cervical Dystonia
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.
Read the 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.
- Conditions
- Torticollis, Cervical Dystonia
- Being tested
- Botulinum Toxin A
- 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
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin ADrug
Also called Botox, Botulinum toxin A
Not exceeding a total dose of 400 units, once every three months.
| Study group | Role | What they receive |
|---|---|---|
| Cervical dystonia (torticollis) | Subjects meeting the criteria fot torticollis who are receiving botulinum toxin injections. Receives: Drug: Botulinum Toxin A | |
| Control | age matched controls with out cervical dystonia (torticollis) Receives: Drug: Botulinum Toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Cortical organizational changes with botulinum toxin treatment in patients with torticollis utilizing magnetoencephalography
Measured: two to eight weeks following treatment
Secondary outcomes (1)
Tsui Torticollis Rating scale
Measured: Two-eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TorticollisStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Naganad Sripathi, Henry Ford Health System
- Investigators
- Naganand Sripathi, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056861
- Sponsor's protocol ID
- 5307
- Other IDs
- 08-0124
- Status last verified
- Apr 2015
- First submitted
- 25 Jan 2010
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Botulinum on the Afferent Input Modulation of Neuronal Circuits Involved in Cervical Dystonia
- ClinicalTrials.gov ID
- NCT01056861
- Acronym / sponsor ID
- 5307
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical dystonia (torticollis) | – | Drug: Botulinum Toxin ASubjects meeting the criteria fot torticollis who are receiving botulinum toxin injections. |
| Control | – | Drug: Botulinum Toxin Aage matched controls with out cervical dystonia (torticollis) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects meeting the criteria for cervical dystonia (torticollis) who are receiving botulinum toxin injections in the Neurology Clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin AAlso: Botox, Botulinum toxin ANot exceeding a total dose of 400 units, once every three months. | Drug | Cervical dystonia (torticollis), Control |
Primary outcome
Evidence of Cortical organizational changes with botulinum toxin treatment in patients with torticollis utilizing magnetoencephalography
Time frame: two to eight weeks following treatment
1 secondary outcome
Tsui Torticollis Rating scale
Time frame: Two-eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naganand Sripathi, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Torticollis and Cervical Dystonia, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Cortical organizational changes with botulinum toxin treatment in patients with torticollis utilizing magnetoencephalography (time frame: two to eight weeks following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.