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Cubital Tunnel Syndrome and Diffusion MRI: A Proof of Concept Study

Primary Purpose

Cubital Tunnel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
magnetic resonance imaging (MRI)
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cubital Tunnel Syndrome

Eligibility Criteria

18 Years - 18 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome.

Exclusion Criteria:

  • Unable to get into the MRI scanner due to habitus or claustrophobia
  • Unable to lie still due to any cause (eg. athetoid movements, dystonias, chorea, etc)
  • Intraocular or intracranial metallic foreign bodies
  • Active implants (eg. pacemakers, implantable cardiac defibrillators, nerve stimulators, etc) which are not MRI safe or conditional.
  • Pregnancy - whilst there are no known adverse effects of MRI16-18 to the mother or fetus, MRI is generally avoided in pregnancy due to the acoustic trauma19 and inductive heating generated by alternating magnetic fields.
  • Any metallic implants in the elbow

Sites / Locations

  • Leeds Teaching Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy volunteers

Patients undergoing surgery

Arm Description

We will include adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome.

Outcomes

Primary Outcome Measures

The question is whether the MRI diffusion metrics of the ulnar nerve in patients with the cubital tunnel
change following surgical decompression.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2020
Last Updated
July 13, 2020
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04470245
Brief Title
Cubital Tunnel Syndrome and Diffusion MRI: A Proof of Concept Study
Official Title
Cubital Tunnel Syndrome and Diffusion Tensor Magnetic Resonance Imaging: A Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Title
Patients undergoing surgery
Arm Type
Active Comparator
Arm Description
We will include adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome.
Intervention Type
Diagnostic Test
Intervention Name(s)
magnetic resonance imaging (MRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The question is whether the MRI diffusion metrics of the ulnar nerve in patients with the cubital tunnel
Description
change following surgical decompression.
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome. Exclusion Criteria: Unable to get into the MRI scanner due to habitus or claustrophobia Unable to lie still due to any cause (eg. athetoid movements, dystonias, chorea, etc) Intraocular or intracranial metallic foreign bodies Active implants (eg. pacemakers, implantable cardiac defibrillators, nerve stimulators, etc) which are not MRI safe or conditional. Pregnancy - whilst there are no known adverse effects of MRI16-18 to the mother or fetus, MRI is generally avoided in pregnancy due to the acoustic trauma19 and inductive heating generated by alternating magnetic fields. Any metallic implants in the elbow
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryckie Wade, MBBS DipHR MClinEd MRCS FHEA
Email
ryckiewade@gmail.com
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryckie Wade

12. IPD Sharing Statement

Learn more about this trial

Cubital Tunnel Syndrome and Diffusion MRI: A Proof of Concept Study

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