A Microneurography Test-Retest Study
Research type
Research Study
Full title
A Microneurography Study to Assess Test-Retest Variability in Healthy Volunteers and in Patients with Diabetic Peripheral Neuropathy
IRAS ID
212545
Contact name
Jordi Serra
Contact email
Sponsor organisation
Merck Sharp & Dohme Limited
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
Diabetes-related peripheral neuropathy (DPN) is a common condition, characterized by chronic spontaneous pain affecting mainly the lower extremities. The exact mechanism of action is still unknown although abnormal spontaneous activity from diseased sensory nociceptors (a class of nerve cells)is generally accepted as the main cause and has a direct input into the central nervous system, causing changes that could contribute to the overall experience of pain. Neuropathic pain is difficult to treat and has a significant impact on patients’ quality of life.
Microneurography (MN) is a minimally invasive technique using small metal electrodes to record nerve impulse traffic. MN can provide information about C-nociceptors by recording and quantifying spontaneous activity both under natural and disease conditions.
A previous clinical study demonstrated the potential use of measuring spontaneous activity in peripheral nociceptors (through MN) as a painkilling measure of change in clinical condition . .
Currently, there are few robust translatable biomarkers (biological parameters indicating a biological condition) to evaluate the effects of treatments for chronic neuropathic pain. As MN is the only technique capable of measuring spontaneous C-nociceptor activity, it is essential to establish this as a potential “translatable” biomarker platform to allow for future neuropathic pain drug development.
The objective of this study is to estimate the precision of the MN endpoints in both healthy subjects and patients with DPN by utilizing a test and re-test study design; to estimate the subject as well as the day-to-day variabilities.
At least 16 male/female subjects, aged between 18-75 years, will enrol on this study which is expected to last approximately 6 months from subject consent through to the last subject’s last study-related communication. No treatment will be administered.
The study is funded by Merck Sharp & Dohme Limited and will take place at one study centre in the UK.REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/1679
Date of REC Opinion
1 Nov 2016
REC opinion
Further Information Favourable Opinion