Cortical Effects of Peripheral Nerve Injury At Birth

August 9, 2016 updated by: Zeynep Tuna, Gazi University

Investigating the Long-Term Cortical Effects of Peripheral Nerve Injury At Birth

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

15

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with obstetrical brachial plexus palsy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Study group
Patients with obstetrical brachial plexus injury involving upper trunk (C5-6)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
voxels
Time Frame: 6 months
voxels (n) are the task-activated volume of brain regions
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active Movement Scale score
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Collaborators

Ataturk Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziU-ZTuna1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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