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

Evaluation of Primary Repaired Wrist Level Complete Median Nerve Transection With Clinical, Electroneuromyographic (ENMG) and Diffusion Tensor Imaging (DTI) Methods

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".

Study Overview

• Status: Unknown
• Conditions: Wound, Healed (Morphologic Abnormality); Injury of Median Nerve
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Turkey
  • Kayseri
    • Melikgazi, Kayseri, Turkey, 38050
      • Recruiting
      • Erciyes University Faculty of Medicine
      • Contact: Ali Eray GUNAY, resisdent; Phone Number: +905556493401; Email: alieraygunay@hotmail.com
      • Contact: İbrahim KARAMAN, docent; Phone Number: 05327183353; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroneuromyography	conventional evaluation of nerve healing - That evaluate axonal transfer speed etc	2 months
Physical Examination	conventional evaluation of nerve healing. That Evaluate sensitivity, motor functions and paresthesia	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffusion Tensor Imaging Methods	new method for evaluation of nerve healing with tissues diffusion on magnetic resonants imaging	2 months

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Collaborators: The Scientific and Technological Research Council of Turkey
• Investigators: Study Director: İbrahim Karaman, ass.doc.dr, TC Erciyes University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: ENMG and MRI on Median Nerve

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. Study Protocol