An interventional study of magnetic resonance imaging (MRI) in Cubital Tunnel Syndrome, sponsored by The Leeds Teaching Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable, Interventional, and Diagnostic
Cubital Tunnel Syndrome (CTS) results from compression of the ulnar nerve at the elbow (colloquially termed the "funny bone"). CTS affects up to 6% of the population and 6000 patients undergo surgery annually in the UK. Surgery is the only proven treatment for CTS, although up to 30% of patients do not improve. Therefore, there is a pressing need to develop a reliable test to diagnose CTS to improve the selection of patients for surgery.
New techniques in the field of magnetic resonance imaging (MRI) allow the visualisation of nerve structure and function. Diffusion tensor MRI, also known as diffusion tensor imaging (DTI), can diagnose CTS with superior diagnostic accuracy and could enable the reliable diagnostic of CTS, improving the selection of patients for surgery.
The study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned preoperatively and postoperatively using cutting-edge diffusion MRI techniques. The primary outcome will be change in the MRI-derived diffusion metrics following surgery. Secondary outcomes will consider how MRI relates to patient-reported outcomes and conventional clinical tests (ultrasound and nerve conduction studies).
Leeds is the ideal location for this research because a) Leeds institutions are the most highly cited organisations in musculoskeletal research, b) Leeds houses the National Centre for Hyperpolarized MRI and a state-of-the-art MRI scanner, and c) Leeds is an internationally recognised centre of excellence for complex upper limb surgery.
35 studies on the registry are indexed under Cubital Tunnel Syndrome; 7 are open to participants now.
This study's planned enrollment of 30 is below the median of 63 across 24 interventional studies indexed under Cubital Tunnel Syndrome.
Browse Cubital Tunnel Syndrome studies →The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diagnostic Test: magnetic resonance imaging (MRI)
We will include adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome.
Diagnostic Test: magnetic resonance imaging (MRI)
Our study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned before and after their operation using cutting-edge diffusion MRI techniques.
The question is whether the MRI diffusion metrics of the ulnar nerve in patients with the cubital tunnel
change following surgical decompression.
Time frame: 60 minutes
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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The Leeds Teaching Hospitals NHS Trust