Feasibility study imaging the sciatic nerve in peripheral neuropathy
Research type
Research Study
Full title
Feasibility study imaging the sciatic nerve in peripheral neuropathy
IRAS ID
272648
Contact name
David Sharp
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Peripheral neuropathy is a common condition associated with numerous other diseases, including diabetes and HIV infection. The neuropathy is often painful and associated with significant morbidity including predisposing to infections and amputations. Despite its prevalence, the root causes and factors associated with disease progression and pain are poorly understood, partly due to the limitations of current methods for investigating neuropathy. We sorely need better methods for identifying disease in peripheral nerves, particularly those that allow repeated testing over time, which is difficult if not impossible for nerve biopsy.
Recent research has shown that there appears to be different types of nerve damage in type 1 and type 2 diabetes as assessed by magnetic resonance imaging (MRI), which were related to different aspects of the disease process (high blood sugar in type 1 and high lipids in type 2 diabetes), but the functional relevance of this is still unclear. To date there has been no MRI study of HIV neuropathy.
Here we propose a feasibility study to use high field strength MRI (7 Tesla), to image sciatic nerves in peripheral neuropathy in type 2 diabetes and HIV infection, to develop sequences and methods of analysing data. We will also deeply phenotype patients using a wide selection of outcome measures, including blood results, electrical studies of nerves, quantitative sensory testing, skin biopsy, and questionnaire surveys, as part of a larger study to be conducted investigating the relationship between MRI changes and other data in diabetes and HIV.
The aims of this study are: i) to assess whether it is possible to recruit from existing cohorts of patients into this trial, and whether the protocol set out here is tolerable to patients taking part; ii) to develop MRI methods for the follow on study; and iii) to start collecting and storing data for the larger study.
Summary of Results
This project was intended to be a pilot study to develop methods of scanning the sciatic nerve at the level of the knee using high feel (7 Tesla) MRI. However due to delays in setting up study, we were required to submit a new ethics approval for a larger multi-centre study (PAINSTORM) which incorporated the same MRI work. Therefore we opted to include all scanning under this new ethical approval to have all PAINSTORM projects under the same ethics. Therefore no participants were ever recruited to this original pilot study.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
20/EM/0196
Date of REC Opinion
27 Jan 2021
REC opinion
Further Information Favourable Opinion