Cortical Effects of Peripheral Nerve Injury At Birth

NCT ID: NCT02865317

Last Updated: 2016-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Peripheral Nerve Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk Training and Research Hospital

OTHER

Sponsor Role collaborator

Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Tuna

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GaziU-ZTuna1

Identifier Type: -

Identifier Source: org_study_id

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