ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Neurological

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]

Not applicable

Comparator / control treatment

Control subjects without neurological disease

Control group

Active

Outcomes

Primary outcome [1]

comparison between sensory testing outcomes in people with cervical dystonia and control subjects

Timepoint [1]

Comparison between groups ( Cervical dystonia compared with healthy controls) will be conducted after all participants have completed their initial visit.

Primary outcome [2]

comparison between sensory testing before and after botulinum toxin injection treatment for cervical dystonia

Timepoint [2]

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]

variability in sensory testing outcomes across affected and non affected body parts in cervical dystonia

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred

Address [1]

Commercial road Prahran Victoria 3004

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Alfred

Address

Commercial road
Prahran
Victoria 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Alfred HREC

Ethics committee address [1]

The Alfred Hospital 
Commercial road
Prahran
Victoria 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/01/2014

Approval date [1]

Ethics approval number [1]

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

Dr Kelly Bertram

Address

Neurosciences Alfred Hospital Commercial road Prahran Victoria 3004

Country

Australia

Phone

+61 3 9076 2000

Fax

[email protected]

Contact person for public queries

Name

Sarah Hewer

Address

Neurosciences Alfred Hospital Commercial road Prahran Victoria 3004

Country

Australia

Phone

+61 3 9076 2000

Fax

[email protected]

Contact person for scientific queries

Name

Kelly Bertram

Address

Neurosciences Alfred Hospital Commercial road Prahran Victoria 3004

Country

Australia

Phone

+61 3 9076 2000

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically