MRI Diffusion Tensor Tractography to Track and Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 6/28/2018 |
| Start Date: | October 2016 |
| End Date: | November 2020 |
| Contact: | Wesley Thayer, MD, PhD |
| Email: | wesley.thayer@vanderbilt.edu |
| Phone: | 615-936-0160 |
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.
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.
Although nerve transfers can reduce the length of axonal growth required, failures still
occur and revisions are rarely an option due to the aforementioned delays in detection.
Current neurodiagnostics [e.g., electromyography (EMG), nerve conduction studies (NCS)] are
of limited utility in severely damaged nerves, providing an incomplete picture of nerve
microstructural features until target reinnervation occurs. Thus, physicians are limited to a
"wait and watch" approach based on qualitative measures obtained from patient history and/or
physical exam. This leads to a suboptimal management of peripheral nerve injuries, which in
turn can lead to increased instances of irreversible muscle atrophy, paralysis, and/or
formation of painful traumatic neuroma.
In terms of the military, extremity injuries accounted for 54% of combat wounds in Operation
Iraqi Freedom and Operation Enduring Freedom and recent review of service member injuries
during Operation Enduring Freedom noted significant increases in brachial plexus, ulnar, and
radial nerve injuries attributable to modern warfare. In addition, symptomatic neuroma occurs
in 13% to 32% of amputees, causing pain and limiting or preventing the use of prosthetic
devices. Take the example of a wounded warrior with a shrapnel injury to his/her elbow,
resulting in the loss of an ulnar nerve segment. Even if nerve grafting is performed, true
recovery (motor and/or sensory innervation of the hand) could take up to a year under typical
circumstances. If the repair fails, which occurs in up to 40% of patients the failure is
typically not truly recognized until that year expires using current management protocols. By
that time, revisional surgery is typically not a viable option due to the aforementioned
onset of irreversible muscle atrophy. In additional to an inability to effectively monitor
nerve recovery after repair, diagnosis of peripheral nerve injuries is difficult using the
currently available methods. For example, neurotmesis is a common, but difficult to
distinguish, diagnosis following traumatic or iatrogenic extremity injury. Current
electrodiagnostic and clinical examinations are invasive, time consuming, and painful. In
addition, they cannot perfectly discriminate a severe axonotmetic laceration from a
self-resolving neurapraxic injury in the acute setting. This is particularly important in
penetrating injuries, or after iatrogenic nerve injuries resulting from nerve blocks, or from
intraoperative positioning or external compression, because the degree of axonal injury is
unknown.
occur and revisions are rarely an option due to the aforementioned delays in detection.
Current neurodiagnostics [e.g., electromyography (EMG), nerve conduction studies (NCS)] are
of limited utility in severely damaged nerves, providing an incomplete picture of nerve
microstructural features until target reinnervation occurs. Thus, physicians are limited to a
"wait and watch" approach based on qualitative measures obtained from patient history and/or
physical exam. This leads to a suboptimal management of peripheral nerve injuries, which in
turn can lead to increased instances of irreversible muscle atrophy, paralysis, and/or
formation of painful traumatic neuroma.
In terms of the military, extremity injuries accounted for 54% of combat wounds in Operation
Iraqi Freedom and Operation Enduring Freedom and recent review of service member injuries
during Operation Enduring Freedom noted significant increases in brachial plexus, ulnar, and
radial nerve injuries attributable to modern warfare. In addition, symptomatic neuroma occurs
in 13% to 32% of amputees, causing pain and limiting or preventing the use of prosthetic
devices. Take the example of a wounded warrior with a shrapnel injury to his/her elbow,
resulting in the loss of an ulnar nerve segment. Even if nerve grafting is performed, true
recovery (motor and/or sensory innervation of the hand) could take up to a year under typical
circumstances. If the repair fails, which occurs in up to 40% of patients the failure is
typically not truly recognized until that year expires using current management protocols. By
that time, revisional surgery is typically not a viable option due to the aforementioned
onset of irreversible muscle atrophy. In additional to an inability to effectively monitor
nerve recovery after repair, diagnosis of peripheral nerve injuries is difficult using the
currently available methods. For example, neurotmesis is a common, but difficult to
distinguish, diagnosis following traumatic or iatrogenic extremity injury. Current
electrodiagnostic and clinical examinations are invasive, time consuming, and painful. In
addition, they cannot perfectly discriminate a severe axonotmetic laceration from a
self-resolving neurapraxic injury in the acute setting. This is particularly important in
penetrating injuries, or after iatrogenic nerve injuries resulting from nerve blocks, or from
intraoperative positioning or external compression, because the degree of axonal injury is
unknown.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-936-0160
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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