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Trial registered on ANZCTR


Registration number
ACTRN12619000429156
Ethics application status
Approved
Date submitted
10/03/2019
Date registered
15/03/2019
Date last updated
15/03/2019
Date data sharing statement initially provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Delayed (F-wave) nerve conduction responses in healthy participants and participants with neuropathy
Scientific title
Neurophysiologic abnormalities detected on single fibre F-wave recordings in healthy participants and participants with neuropathy
Secondary ID [1] 297684 0
None
Universal Trial Number (UTN)
Trial acronym
SFF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral neuropathy 311963 0
Diabetes (type 1 or 2) 311964 0
Impaired glucose tolerance 311965 0
Condition category
Condition code
Neurological 310540 310540 0 0
Other neurological disorders
Metabolic and Endocrine 310541 310541 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will take place at St Vincent's Hospital Melbourne. A neurologist or neurology fellow will perform a single assessment. The assessment with take approximately 45-60 minutes. Routine nerve conduction studies (using an EMG machine) will be performed using surface electrode recordings. Using a fine concentric needle nerve conduction recordings are performed on a hand (first dorsal interosseous) and foot (extensor digitorum brevis) muscle. Nerve excitability testing, where a train of stimulations using surface electrode recordings of varying intensity, will be performed on a hand muscle (abductor pollicis brevis). Single fibre F-waves and peripheral nerve excitability are novel techniques used to detect early neuropathy so both healthy participants (controls) and participants with diabetes/impaired glucose tolerance and/or neuropathy will be tested. The head of neurophysiology (LR) St Vincent's Hospital Melbourne will monitor adherence to the trial protocol.
Intervention code [1] 313917 0
Early detection / Screening
Comparator / control treatment
Data from health controls will form the comparator group from which comparison to participants with diabetes and/or neuropathy will be made.
Control group
Active

Outcomes
Primary outcome [1] 319402 0
Percentage abnormality on conventional nerve conduction studies (including conventional F-waves) using an EMG machine
Timepoint [1] 319402 0
Single assessment
Primary outcome [2] 319403 0
Percentage abnormality on single fibre F-waves using an EMG machine
Timepoint [2] 319403 0
Single assessment
Primary outcome [3] 319404 0
Percentage abnormality on peripheral nerve excitability testing using an EMG machine
Timepoint [3] 319404 0
Single assessment
Secondary outcome [1] 368032 0
N/A
Timepoint [1] 368032 0
N/A

Eligibility
Key inclusion criteria
• 18 - 75 years old
• Healthy participants
OR
• Participants with diabetes (type 1 or 2) with or without neuropathy
OR
• Participants with impaired glucose tolerance with or without neuropathy
OR
• Participants with neuropathy due to a single other aetiology
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Other causes of neuropathy in participants with diabetes or impaired glucose tolerance (i.e. multiple causes of neuropathy) including B12 deficiency, alcohol excess, neurotoxic drugs or chemotherapy, autoimmune disease, acquired demyelinating neuropathy, hereditary neuropathy or malignancy
• Other disease process that can affect target single fibre F-wave / conventional F-wave responses in all accessible limbs
• Less than 1 arm and 1 leg accessible by routine nerve conduction studies
• INR > 3.0 on warfarin therapy
• Known congenital or acquired coagulopathy
• History of haemorrhage taking novel oral anticoagulants e.g. dabigatran, rivaroxaban and apixaban.
• Unable to provide consent or undertake assessment
• Chronic or active infection overlying the muscle to be sampled
• Pregnant
• Previous intolerance to nerve conduction studies / electromyography
• Serious comorbidity which in the opinion of the local investigator could increase participant risk by participation in the study e.g. respiratory compromise
• For nerve excitability testing: participants with moderate or greater degree carpal tunnel syndrome or current use of sodium channel blocking medications

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Healthy controls: a sample size of at least 100, including at least 20 participants > 60 years old, was chosen as this is considered to carry adequate power and precision for normative data (Dillingham et al. Muscle & Nerve, 2016).

Participants with diabetes: Using a Pearson Chi square test based on results of a pilot study (Jordan et al, Muscle & Nerve, 2018), a sample size of 31 participants with no or mild neuropathy is required to achieve 80% power with a one-sided 5% significance level.

Participants with moderate or severe diabetic neuropathy, impaired glucose tolerance and other neuropathies: As many as can be recruited within 12 months. This study is not powered specifically for comparative purposes in these diseases so a feasible recruitment period was selected.

The percentage of abnormal routine sensory and motor studies, conventional F-waves, single fibre F-waves (compared to obtained healthy control data) and nerve excitability parameters will be calculated. Chi square test will be used for comparing percentages.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2019
Actual
Date of last participant enrolment
Anticipated
23/03/2020
Actual
Date of last data collection
Anticipated
23/03/2020
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302210 0
Self funded/Unfunded
Name [1] 302210 0
Dr Leslie Roberts
Country [1] 302210 0
Australia
Primary sponsor type
Individual
Name
Dr Leslie Roberts
Address
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 302058 0
None
Name [1] 302058 0
Address [1] 302058 0
Country [1] 302058 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302888 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 302888 0
Ethics committee country [1] 302888 0
Australia
Date submitted for ethics approval [1] 302888 0
20/11/2018
Approval date [1] 302888 0
25/02/2019
Ethics approval number [1] 302888 0
47689

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91746 0
Dr Leslie Roberts
Address 91746 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Country 91746 0
Australia
Phone 91746 0
+61 3 92312211
Fax 91746 0
Email 91746 0
Leslie.ROBERTS@svha.org.au
Contact person for public queries
Name 91747 0
Sam Law
Address 91747 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Country 91747 0
Australia
Phone 91747 0
+61 3 92312211
Fax 91747 0
Email 91747 0
sam.law2@svha.org.au
Contact person for scientific queries
Name 91748 0
Sam Law
Address 91748 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC 3065
Country 91748 0
Australia
Phone 91748 0
+61 3 92312211
Fax 91748 0
Email 91748 0
sam.law2@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To preserve participant confidentiality.


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.