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Cortical Effects of Peripheral Nerve Injury At Birth

Sponsor
Gazi University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02865317
Collaborator
Ataturk Training and Research Hospital (Other)
15
Enrollment
3
Duration (Months)

Study Details

Study Description

Brief Summary

Cortical activity during rest and with stimulation by functional magnetic resonance imaging will be investigated in patients with OBPI.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Peripheral nerve injury results in a number of cortical changes due to the lack of sensory and motor stimuli. Although functional magnetic resonance imaging (fMRI) studies that revealed the changes in the cortical activation exist, the cortical activation changes in obstetrical brachial plexus injury is poorly known. For this reason, the aim of this study is to investigate the cortical activity during rest and with stimulation by fMRI in patients with OBPI.

    Patients with OBPI diagnosis in the cervical 5-6 (C5-6) (upper trunk) who are followed up in Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation Division of Hand Rehabilitation will participate in the study. Patients with a surgery history at least 5 years ago and over 10 years age will be included. Clinical motor and sensory assessments will be performed to help in explaining the analyses of cortical activation. In their first visit, clinical assessments including Active Movement Scale, modified Mallet Classification (MMC) and sensory tests will be performed; while fMRI scanning will be carried out in the second visit. Patients will be scanned for 3 paradigms at one single fMRI session: at rest and during sensory stimulation and watching videos of motor movements. Video images will include the 5 movements used in MMC and will be watched by glasses integrated in the MRI device. Images obtained from MR scanning will be analyzed with analysis programs like Leonardo, Fresurfer, SPM, BrainVoyager and clinical results will be compared to MR images.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Investigating the Long-Term Cortical Effects of Peripheral Nerve Injury At Birth
    Study Start Date :
    Oct 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2016
    Anticipated Study Completion Date :
    Jan 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Study group

    Patients with obstetrical brachial plexus injury involving upper trunk (C5-6)

    Outcome Measures

    Primary Outcome Measures

    1. voxels [6 months]

      voxels (n) are the task-activated volume of brain regions

    Secondary Outcome Measures

    1. Active Movement Scale score [6 months]

      AMS is a clinical outcome measure that evaluates patient's affected arm movements.This tool is used to quantify upper extremity strength by observing spontaneous, active movement both without and against gravity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • upper trunk (cervical 5-6) involvement

    • cooperated

    Exclusion Criteria:

    • illiterate

    • surgical history for his arm in the previous 5 years

    • other than only C5-6 involvement

    • any impairment that prevents positioning in MRI machine

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Gazi University
    • Ataturk Training and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeynep Tuna, Principal Investigator, Gazi University
    ClinicalTrials.gov Identifier:
    NCT02865317
    Other Study ID Numbers:
    • GaziU-ZTuna1
    First Posted:
    Aug 12, 2016
    Last Update Posted:
    Aug 12, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Peripheral Nerve Injuries
    Wounds and Injuries

    Study Results

    No Results Posted as of Aug 12, 2016