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

Sponsor
TC Erciyes University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02672631
Collaborator
The Scientific and Technological Research Council of Turkey (Other)
20
1
10
2

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Jan 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2016
Anticipated Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Electroneuromyography
  • Outcome Measures

    Primary Outcome Measures

    1. Electroneuromyography [2 months]

      conventional evaluation of nerve healing - That evaluate axonal transfer speed etc

    2. Physical Examination [2 months]

      conventional evaluation of nerve healing. That Evaluate sensitivity, motor functions and paresthesia

    Secondary Outcome Measures

    1. Diffusion Tensor Imaging Methods [2 months]

      new method for evaluation of nerve healing with tissues diffusion on magnetic resonants imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erciyes University Faculty of Medicine Melikgazi Kayseri Turkey 38050

    Sponsors and Collaborators

    • TC Erciyes University
    • The Scientific and Technological Research Council of Turkey

    Investigators

    • Study Director: İbrahim Karaman, ass.doc.dr, TC Erciyes University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Feb 3, 2016
    Last Update Posted:
    Feb 3, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2016