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NCT02960516 · ClinicalTrials.gov registry record

MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury

A clinical trial, sponsored by Vanderbilt University.

Completed
Registry status
19
Enrollment target

NCT02960516: Completed study, sponsored by Vanderbilt University.

NCT02960516 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02960516 has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
19 participants
Enrollment target

Study Summary

It is estimated that up to 5% of all admissions to level one trauma centers have a peripheral nerve injury. These peripheral nerve injuries may have devastating impacts on quality of life and require months or years to regain function. Neurotmesis, or peripheral nerve transection, is a common injury, with singly cut nerve lacerations accounting for over 60% of the peripheral nerve surgical interventions in civilian studies. For recovery to occur in these patients, axons must grow from the site of repair to the target tissues, a length of up to a meter in humans. By that time, revisional surgery may not be a viable option due to the onset of irreversible muscle atrophy - a transected nerve is estimated to induce a loss of achievable function of approximately 1% for every 6 days of delay. The scenario is even worse for more proximal nerve injuries, such as those that occur in the brachial plexus. The investigators aim is to longitudinally assess diffusion tensor tractography (DTI) in order to optimize, validate, and translate the ability of DTI to monitor and, more importantly, predict nerve regrowth following trauma and surgical repair. The overall objective of this study is to evaluate the ability of (DTI) to monitor and, more importantly, predict nerve regrowth following crush or cut with surgical repair. The investigators hypothesize that the additional information available via DTI will improve our ability to monitor and predict nerve regrowth following surgical repair or severe crush injury, guiding clinical management either toward or away from surgical intervention.

Primary Outcome

Michigan Hand Questionnaire assesses hand function and well being of patients with hand injuries. It is divided into 6 scales: Overall hand function, scored in a range of 5-25; Activities of daily living, scored in a range of 5-25; Work, scored in a range of 5-25; Pain, scored in a range of 5-25; Aesthetics, scored in a range of 4-16; Satisfaction, scored in a range of 6-30. For the pain scale, higher scores indicate more pain. For the other 5 scales, higher scores indicate better hand perform

Interventions

  • DEVICE MRI of 3.0T

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2016-10
Est. Completion 2021-07-29
Vanderbilt University

430 total trials

What the finished NCT02960516 record still lists

NCT02960516 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which MRI of 3.0T is the first listed.

NCT02960516 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02960516 about?

NCT02960516 is a clinical study titled "MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury". It is estimated that up to 5% of all admissions to level one trauma centers have a peripheral nerve injury. These peripheral nerve injuries may have devastating impacts on quality of life and require months or years to regain function. Neurotmesis, or peripheral nerve transection, is a common injury...

What is the current status of trial NCT02960516?

This trial is currently completed. The enrollment target is 19 participants. The study started on 2016-10. Estimated completion is 2021-07-29.

What interventions are being tested in trial NCT02960516?

The interventions under investigation include: MRI of 3.0T (DEVICE).

Who is sponsoring clinical trial NCT02960516?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02960516, the US trial registry maintained by the National Library of Medicine. NCT02960516 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.