N/A
N=19
MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury
Nerve Injury
Bottom Line
View on ClinicalTrials.gov: NCT02960516 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery — 33; 83; 5; 75 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MRI of 3.0T (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery |
33; 83; 5; 75; 69; 83 | — |
| PRIMARY Grip Strength in Subjects With TPNI Post Surgery |
NA; 92; 30; 75; 40; 100 | — |
| PRIMARY 9 Hole Peg Test in Subjects With TPNI |
NA; 23; 43; 27; 100; 27 | — |
| PRIMARY Diffusion Tensor Imaging (DTI) Diffusivity Metrics Post Surgery |
1.41; 1.13; 1.27; 1.09; 1.91; 1.82 | — |
| PRIMARY Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Metric Post Surgery |
0.32; 0.48; 0.43; 0.59 | — |
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.
Eligibility Criteria
Inclusion Criteria
subjects between ages of 18 and 64 year of age diagnosed with a Sunderland Class V traumatic neuropathy (transection injury) of the upper extremity nerves that require repair
- Candidates for immediate operative repair of this injury and do not have significant medical comorbidities precluding immediate operative intervention
- willing to comply with all aspects of the treatment (post-operative visits, occupational therapy) and evaluation schedule over the following 12 months
- have peripheral nerve injuries complicated by significant vascular or orthopedic damage
Exclusion Criteria
- Injuries exhibit gross contamination
- soft tissue coverage is inadequate
- planned staged repair
- have diabetes
- have a neuromuscular disease
- undergoing chemotherapy, radiation therapy or other treatments known to affect the growth of the neural and vascular system
- unlikely to complete occupational therapy
- pregnant or breast-feeding
- subject with any ferromagnetic objects that cannot be removed (cardiac pacemakers, aneurysm clips etc).
- history of claustrophobia
Data sourced from ClinicalTrials.gov (NCT02960516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.