Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000311651
Ethics application status
Approved
Date submitted
12/03/2023
Date registered
22/03/2023
Date last updated
22/03/2023
Date data sharing statement initially provided
22/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exteroceptive Reflexes in Neurological Conditions and Healthy Controls
Scientific title
Exteroceptive Reflexes in Neurological Conditions and Healthy Controls
Secondary ID [1] 309188 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stiff Person Syndrome 329328 0
Parkinson's Disease 329329 0
Multiple Sclerosis 329330 0
Hereditary Spastic Paraplegia 329331 0
Lower limb dystonia 329332 0
Back pain 329333 0
Condition category
Condition code
Neurological 326272 326272 0 0
Multiple sclerosis
Neurological 326273 326273 0 0
Parkinson's disease
Neurological 326274 326274 0 0
Other neurological disorders
Neurological 326275 326275 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exteroceptive reflex testing is a neurophysiological test that measures the response of a person's muscles following stimulation of nerves in the arms and legs. In this study exteroceptive reflexes of participants with Stiff Person Syndrome, Parkinson’s disease, Spasticity due to Multiple sclerosis and hereditary spastic paraplegia, lower limb dystonia and subacute-chronic back pain, healthy participants and those without neurological conditions but taking some antidepressant medications (selective serotonin reuptake inhibitors and selective serotonin and noradrenaline reuptake inhibitors) will be compared.

Exteroceptive reflex testing will be performed by a neurologist trained in neurophysiology. The testing in addition to demographic data collection will occur in a single session, which will take approximately 90 minutes. In line with published techniques, stimulus-train stimulation of the median and tibial nerve will be performed bilaterally, 8 times at each site.
The stimulus-train is of frequency 200Hz, lasts a total of 0.2ms and will be performed 8 times to each of the median and tibial nerves. An interval of at least 30seconds will separate each stimulus train at each site.

Muscle activity will be recorded by surface electromyography at the sternocleidomastoid, paraspinal muscles (C7, T4, T10, L4), rectus abdominus, rectus femoris and tibialis anterior muscles. The latency, sequence and pattern of motor activation following stimulation will be compared.
Intervention code [1] 325633 0
Not applicable
Comparator / control treatment
There is no treatment in this observational study, however healthy participants will act as the control group. Results of exteroceptive testing will be compared between groups of participants with neurological conditions or taking medication which may impact these results, and also with healthy participants.
Control group
Active

Outcomes
Primary outcome [1] 334143 0
The frequency of abnormal exteroceptive reflex tests, as measured by latency of onset of EMG activity following median and tibial nerve stimulation, in those with Stiff Person Syndrome and other neurological conditions, healthy participants and participants with no neurologic disease but taking some classes of medications.
Timepoint [1] 334143 0
Single timepoint only
Secondary outcome [1] 419464 0
Comparison between study groups in the specific sequence of EMG activity following median and tibial nerve stimulation. .
Timepoint [1] 419464 0
Single timepoint only
Secondary outcome [2] 419786 0
Comparison between study groups in the presence of after-bursts on EMG following median and tibial nerve stimulation.
Timepoint [2] 419786 0
Single Timepoint only
Secondary outcome [3] 419787 0
Comparison between study groups in the duration of EMG activity following median and tibial nerve stimulation.
Timepoint [3] 419787 0
Single timepoint only

Eligibility
Key inclusion criteria
- Diagnosis of antibody positive stiff-person syndrome, Multiple sclerosis with spasticity, hereditary spastic paraplegia, lower limb dystonia, Parkinson’s disease, no neurological illness but taking selective serotonin reuptake inhibitors or selective serotonin and noradrenaline reuptake inhibitors, healthy volunteers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contact allergy to medical adhesives

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics for clinical and demographic variables will be performed.
The main purpose of this study is to describe the patterns of exteroceptive reflexes in different conditions. The continuous measures (latency of EMG activity, duration of muscle activity) will be inspected visually as histograms and will be described with point (mean or median) and interval estimates (standard deviation or quartiles) as appropriate. Categorical measures (presence/absence of after bursts) will be presented as a proportion, with variance derived from binomial distribution. Within-group variability of measures will be quantified with a coefficient of variation. Where appropriate, point estimates will be compared with inferential methods. Generalised linear models with appropriate distributions will be used to compare differences between groups with different diagnoses. Side-side differences and rostro-caudal differences will be compared with generalized mixed effect models. Confounders of the associations will be explored in univariate models; those with sufficient evidence for potential association with the outcome (p=0.1) will be included in multivariable models as adjustment variables.

Multinomial logistic regression analysis will also be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 24274 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 24275 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 39815 0
2145 - Westmead
Recruitment postcode(s) [2] 39814 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 313385 0
Hospital
Name [1] 313385 0
The Royal Melbourne Hospital
Country [1] 313385 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
300 Grattan St
Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 315150 0
None
Name [1] 315150 0
Address [1] 315150 0
Country [1] 315150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312601 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 312601 0
The Royal Melbourne Hospital
Level 2 South West
300 Grattan St
Parkville VIC 3050
Ethics committee country [1] 312601 0
Australia
Date submitted for ethics approval [1] 312601 0
Approval date [1] 312601 0
08/11/2022
Ethics approval number [1] 312601 0

Summary
Brief summary
Stiff Person Syndrome (SPS) is a rare disorder that causes pain, stiffness and spasms in the back, trunk, arms legs. It can be a difficult condition for doctors to diagnose as the key symptoms are common with many potential causes, and there is no single test that proves a person has the condition. Blood tests can be helpful in some cases and abnormalities in a particular test called the exteroceptive reflex test has been described in the condition. It is not known, however, how accurate exteroceptive reflex testing is in the diagnosis of SPS.

The purpose of this study is to get more information about whether the exteroceptive reflex test can help doctors diagnose stiff-person syndrome and distinguish this from other neurological problems which present with pain or stiffness in muscles, people who take medication which make other reflexes more prominent (selective serotonin reuptake inhibitors and selective serotonin and noradrenaline reuptake inhibitors), and from healthy individuals.

Exteroceptive reflex testing involves a doctor or neurophysiology scientist recording signals from several muscles in the back and legs by placing small disposable recording electrodes on the skin. Muscle contraction is measured after nerves in the wrist and ankle are activated with low-level electrical current. The test takes approximately 15 minutes, and does not cause any harm to the nerves, muscles or other parts of the body.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125250 0
Dr Dr Belinda Cruse
Address 125250 0
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 125250 0
Australia
Phone 125250 0
+61 03 93427693
Fax 125250 0
Email 125250 0
belinda.cruse@mh.org.au
Contact person for public queries
Name 125251 0
Mr Callum Hollis
Address 125251 0
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 125251 0
Australia
Phone 125251 0
+61 03 93427693
Fax 125251 0
Email 125251 0
clinicalneurophysiology@mh.org.au
Contact person for scientific queries
Name 125252 0
Dr Belinda Cruse
Address 125252 0
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 125252 0
Australia
Phone 125252 0
+61 03 93427693
Fax 125252 0
Email 125252 0
belinda.cruse@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data only where participants have consented to data being used for other research.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
researchers who provide a methodologically sound proposal with ethics approval, on a case-by-case basis, at the discretion of the primary investigators.
Available for what types of analyses?
only to achieve the aims in the approved proposal.
How or where can data be obtained?
access subject to approval by Principal Investigator, phone +61 03 93427693


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.

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