Cortical Effects of Peripheral Nerve Injury At Birth

Peripheral Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02865317
• Other study ID #: GaziU-ZTuna1
• Status: Not yet recruiting
• Phase: N/A
• First received: January 29, 2016
• Last updated: August 9, 2016
• Start date: October 2016
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Peripheral Nerve Injury
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gazi University	Ataturk Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	voxels	voxels (n) are the task-activated volume of brain regions	6 months	No
Secondary	Active Movement Scale score	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	No