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Trial registered on ANZCTR


Registration number
ACTRN12614000118606
Ethics application status
Not yet submitted
Date submitted
24/01/2014
Date registered
30/01/2014
Date last updated
30/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Sensory Perception in Cervical Dystonia
Scientific title
Evaluating Sensory Perception in Cervical Dystonia
Secondary ID [1] 283977 0
Nil
Universal Trial Number (UTN)
U1111-1152-5351
Trial acronym
ESP CD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Dystonia 291004 0
Condition category
Condition code
Neurological 291350 291350 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study- Sensory testing including Quantitative Sensory analysis and nerve conduction studies.
Quantitative Sensory Analysis (QST) will be performed testing pressure, temperature and pain perception. These tests take 2-3 hours to complete.
Control subjects will undergo this testing on a single occasion. Subjects with Cervical Dystonia will undergo this testing on two separate occasions 6 weeks apart.
Intervention code [1] 288665 0
Not applicable
Comparator / control treatment
Control subjects without neurological disease
Control group
Active

Outcomes
Primary outcome [1] 291346 0
comparison between sensory testing outcomes in people with cervical dystonia and control subjects
Timepoint [1] 291346 0
Comparison between groups ( Cervical dystonia compared with healthy controls) will be conducted after all participants have completed their initial visit.
Primary outcome [2] 291347 0
comparison between sensory testing before and after botulinum toxin injection treatment for cervical dystonia
Timepoint [2] 291347 0
Comparison between sensory testing before and after botulinum toxin injection treatment for cervical dystoniarequires two tests to be performed in each subject with cervical dystonia.
Each participant with cervical dystonia will under go the testing on two separate occasions, with the second testing session taking place after the administration of the participant's next botulinum toxin injection for the treatment of cervical dystonia; testing sessions will be at least 6 weeks apart.
Secondary outcome [1] 306562 0
variability in sensory testing outcomes across affected and non affected body parts in cervical dystonia
Timepoint [1] 306562 0
this information will be collected during the first testing session in subjects with cervical dystonia

Eligibility
Key inclusion criteria
Two groups:
1. Cervical dystonia
Cervical dystonia as diagnosed by a movement disorders neurologist, aged > 18 years, capable of providing informed consent. The first visit will be held at the end of the botulinum toxin injection cycle, 12 weeks since last injection.
2. control subjects without known neurological disease or chronic pain syndrome
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.Complex dystonia phenotype or familial dystonia
2.Presence of neuropathy (including risk factors as detailed below)
a.Diabetes
b.Carpal tunnel syndrome
c.Major cardiac/respiratory/renal impairment
d.Deranged thyroid function
e.Significant B12 deficiency
f.Autoimmune disease
g. Past history of multiple myeloma, chemotherapy
h.Cervical spine pathology/radiculopathy
i.Co-existing neurological disease or other movement disorder
j.Pregnancy
k. Drug and alcohol abuse
l.HepB/HepC/HIV
3.Inability to speak English to sufficient degree to provide appropriate consent
4.Clinically diagnosed dementia
5.Clinically significant generalised pain disorders including
a.Migraine
b.Back pain
c.Fibromyalgia
d.Bruxism/TMJ dysfunction
e.CRPS

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data found to be normally distributed is presented as mean and standard deviation, with comparison between groups made using the independent groups t-test. Data found not to adhere to a normal distribution is presented as median and interquartile range, and differences between groups compared using a Mann-Whitney U-test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2014
Actual
Date of last participant enrolment
Anticipated
1/09/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1997 0
The Alfred - Prahran
Recruitment postcode(s) [1] 7720 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 288606 0
Hospital
Name [1] 288606 0
The Alfred
Country [1] 288606 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Commercial road
Prahran
Victoria 3004
Country
Australia
Secondary sponsor category [1] 287316 0
None
Name [1] 287316 0
Address [1] 287316 0
Country [1] 287316 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290468 0
Alfred HREC
Ethics committee address [1] 290468 0
The Alfred Hospital
Commercial road
Prahran
Victoria 3004
Ethics committee country [1] 290468 0
Australia
Date submitted for ethics approval [1] 290468 0
28/01/2014
Approval date [1] 290468 0
Ethics approval number [1] 290468 0

Summary
Brief summary
Dystonia is a movement disorder characterised by involuntary twisting movements and abnormal postures of the body. Cervical dystonia is the most common focal dystonia of younger adults, producing abnormal neck postures, twisting, shaking and turning movements of the neck, and pain in the neck and shoulders. How dystonia develops is not known. Treatment for cervical dystonia is predominantly with Botulinum toxin. There is compelling evidence for its benefit in reducing symptoms of head posturing and pain, however it requires repeated injections and does not always provide satisfactory outcomes. Botulinum toxin is known to interrupt neuro-muscular interaction, producing focal muscle weakness, however evidence for its use in migraine headache has implicated a direct effect on pain perception. Whether improvement in dystonia with botulinum toxin is related only to motor effects or has a longer term benefit on modulating the dystonia itself is not known. The experience of pain can alter sensory and motor processing related to direct interference with neuroplastic processes or compromised motor performance. Sensory testing has shown decreased sensory function in the affected compared with unaffected hand in people with hand dystonia. This type of sensory testing has not been performed in people with cervical dystonia. It is likely all dystonia arises from abnormal sensorimotor integration processes, though this process is currently incompletely understood.
This project aims to measure peripheral sensory perception objectively in patients with cervical dystonia to determine if their sensation is abnormal, if this is a generalised or focal situation, and to determine if this sensation is altered by the administration of botulinum toxin which is effective in reducing the severity of the movements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45842 0
Dr Kelly Bertram
Address 45842 0
Neurosciences
Alfred Hospital
Commercial road
Prahran
Victoria 3004
Country 45842 0
Australia
Phone 45842 0
+61 3 9076 2000
Fax 45842 0
Email 45842 0
k.bertram@alfred.org.au
Contact person for public queries
Name 45843 0
Dr Sarah Hewer
Address 45843 0
Neurosciences
Alfred Hospital
Commercial road
Prahran
Victoria 3004
Country 45843 0
Australia
Phone 45843 0
+61 3 9076 2000
Fax 45843 0
Email 45843 0
s.hewer@alfred.org.au
Contact person for scientific queries
Name 45844 0
Dr Kelly Bertram
Address 45844 0
Neurosciences
Alfred Hospital
Commercial road
Prahran
Victoria 3004
Country 45844 0
Australia
Phone 45844 0
+61 3 9076 2000
Fax 45844 0
Email 45844 0
k.bertram@alfred.org.au

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No Supporting Document Provided



Results publications and other study-related documents

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