None listed
Conditions
Brief summary
Nerve conduction studies is the study of motor and sensory nerve function by measuring electrical parameters, e.g. velocity and amplitude, of peripherally (e.g. arm or leg) stimulated nerves. Stimulation and recording is typically performed by surface electrodes (metal conductors applied to the skin). Abnormalities on nerve conduction studies can usually be detected in established neuropathy but in early neuropathy nerve conduction studies may remain normal. F-waves are electrical responses stimulated and recorded at the periphery (e.g. hand or feet) that travel from the periphery (e.g. hand or feet) to the spinal cord and back similar to a rebound or boomerang. F-waves are more sensitive at detecting changes consistent with early diabetic neuropathy when examination of other nerves is normal. Preliminary evidence has shown that the study of F-waves using a fine needle in a muscle, so-called ‘single fibre F-waves’, is more precise and sensitive than surface electrodes in detecting early neuropathy in patients with diabetes. The purpose of this trial is to ascertain the utility of single fibre F-waves in comparison to nerve excitability testing and routine nerve conduction studies in patients with neuropathy or risk factors for neuropathy (i.e. diabetes/impaired glucose tolerance).
Interventions
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 stim
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.
Sponsors
Dr Leslie Roberts
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed