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Evaluation of Complete Median Nerve Transection With Clinical, Electroneuromyographic and Diffusion Tensor Imaging

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ClinicalTrials.gov Identifier: NCT02672631
Recruitment Status : Unknown
Verified January 2016 by İbrahim Karaman, TC Erciyes University.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
The Scientific and Technological Research Council of Turkey
Information provided by (Responsible Party):
İbrahim Karaman, TC Erciyes University

Brief Summary:

The aim of this study is to determine whether clinical, sensory and motor development correlated with the values obtained from Electroneuromyography and DTI in postoperative follow up patients who underwent primary repair after the total median nerve injuries.

Median nerve is one of three major nerves of hand and forearm and often injure with glass etc, in follow up of healing; clinical examination and ENMG are often used. Both of these methods are subjective, noninvasive and objective new method is required. In this context; differences between intact, recovering and not healed nerve tissue's diffusions have led to the hypothesis; "The recovery of the repaired nerve tissue can be monitored by Diffusion Tensor Imaging method".


Condition or disease Intervention/treatment
Wound, Healed (Morphologic Abnormality) Injury of Median Nerve Other: physical examination Other: DTI Other: ENMG

Detailed Description:

The aim of this study is to determine whether clinical, sensory and motor development correlated with the values obtained from Electroneuromyography and DTI in postoperative follow up patients who underwent primary repair after the total median nerve injuries.

Median nerve is one of three major nerves of hand and forearm. It is below flexor tendon and retinaculum at the level of the wrist and often injured at this level and subtotally. The primary microsurgical suture technique under a microscope is the gold standard treatment. In follow up of healing; clinical examination and ENMG are often used. Both of these methods are subjective, although ENMG is more objective, however that is an invasive method, and need experienced neurologists. So, noninvasive and objective new method is required. In this context; differences between intact, recovering and not healed nerve tissue's diffusions have led to the hypothesis; "The recovery of the repaired nerve tissue can be monitored by Diffusion Tensor Imaging method". There is no similar study in the literature.

Ten patients who were operated for median nerve injuries in 2014 will be enrolled. In the sample, correlations between Tinnel Test, motor strength assessment (Medical Research Council (MRC) Scale), static two-point discrimination test (S2PD), Semmes-Weinstein (SW) monofilament test, the Disability of the Arm, Shoulder and Hand (DASH) test, EMG with the DTI results will be assessed.

At the end of the study; it is expected that a significant correlation between conventional methods and DTI. If the results support the hypothesis; DTI may get to the literature as noninvasive and objective method in follow of nerve regeneration.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Primary Repaired Wrist Level Complete Median Nerve Transection With Clinical, Electroneuromyographic (ENMG) and Diffusion Tensor Imaging (DTI) Methods
Study Start Date : January 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Median Nerve injury hand
Participants will be randomly called; and that 10 participants which had unilateral median nerve transection totally and repaired primely in our clinic at 2014. In the sample, correlations between physical examination (Tinnel Test, motor strength assessment (Medical Research Council (MRC) Scale), static two-point discrimination test (S2PD), Semmes-Weinstein (SW) monofilament test, the Disability of the Arm, Shoulder and Hand (DASH) test), ENMG with the DTI results will be assessed.
Other: physical examination
Investigators will apply for evaluate clinical median nerve function to all of groups. (Adductor pollicis power (x/5), sense exam(normal/hipoestesia/anestesia) of hand, tinnel test(+/-), DASH score, DN4 neuropathic pain score)

Other: DTI
Investigators will apply for evaluate median nerve healing countable results to all of groups (apparent diffusion coefficient for avarage diffusion (ADC) and fractional anisotropy diffusion orientation(FA) - FA :0 means diffusion is homogenic FA:1 means tissue has heterogenic diffusion
Other Name: Diffusion Tensor Imaging

Other: ENMG
Investigators will apply for evaluate median nerve healing countable results to all of groups. And they will evaluate motor nerve transmission speed, sensitive nerve transmission speed and united muscle action potential
Other Name: Electroneuromyography

Healthy Hand
Control group will be taken from patients other hand which had not injured before. And we will compare with first group's results.
Other: physical examination
Investigators will apply for evaluate clinical median nerve function to all of groups. (Adductor pollicis power (x/5), sense exam(normal/hipoestesia/anestesia) of hand, tinnel test(+/-), DASH score, DN4 neuropathic pain score)

Other: DTI
Investigators will apply for evaluate median nerve healing countable results to all of groups (apparent diffusion coefficient for avarage diffusion (ADC) and fractional anisotropy diffusion orientation(FA) - FA :0 means diffusion is homogenic FA:1 means tissue has heterogenic diffusion
Other Name: Diffusion Tensor Imaging

Other: ENMG
Investigators will apply for evaluate median nerve healing countable results to all of groups. And they will evaluate motor nerve transmission speed, sensitive nerve transmission speed and united muscle action potential
Other Name: Electroneuromyography




Primary Outcome Measures :
  1. Electroneuromyography [ Time Frame: 2 months ]
    conventional evaluation of nerve healing - That evaluate axonal transfer speed etc

  2. Physical Examination [ Time Frame: 2 months ]
    conventional evaluation of nerve healing. That Evaluate sensitivity, motor functions and paresthesia


Secondary Outcome Measures :
  1. Diffusion Tensor Imaging Methods [ Time Frame: 2 months ]
    new method for evaluation of nerve healing with tissues diffusion on magnetic resonants imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ten patients who were operated for median nerve injuries in 2014 will be enrolled. In the sample, correlations between Tinnel Test, motor strength assessment (Medical Research Council (MRC) Scale), static two-point discrimination test (S2PD), Semmes-Weinstein (SW) monofilament test, the Disability of the Arm, Shoulder and Hand (DASH) test, EMG with the DTI results will be assessed.
Criteria

Inclusion Criteria:

  • 18 - 40 years old
  • Total and isolated median nerve transection

Exclusion Criteria:

  • Under 18 and over 40 years old
  • Partially transection of median nerve
  • Median nerve transection with radial or ulnar nerve injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672631


Contacts
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Contact: Ali Eray Günay +905556493401 alieraygunay@hotmail.com
Contact: İbrahim Karaman, ass.doc.dr +903522076666 ext 21307 drikaraman@gmail.com

Locations
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Turkey
Erciyes University Faculty of Medicine Recruiting
Melikgazi, Kayseri, Turkey, 38050
Contact: Ali Eray GUNAY, resisdent    +905556493401    alieraygunay@hotmail.com   
Contact: İbrahim KARAMAN, docent    05327183353    drikaraman@gmail.com   
Principal Investigator: Ahmet Güney, Docent         
Principal Investigator: Mithat Öner, Docent         
Principal Investigator: Serap Doğan         
Principal Investigator: Mehmet Fatih Yetkin         
Principal Investigator: Ali Eray Günay, resident         
Sponsors and Collaborators
TC Erciyes University
The Scientific and Technological Research Council of Turkey
Investigators
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Study Director: İbrahim Karaman, ass.doc.dr TC Erciyes University
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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Responsible Party: İbrahim Karaman, assistant professor doctor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT02672631    
Other Study ID Numbers: ENMG and MRI on Median Nerve
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Congenital Abnormalities