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Clinical Trials/NCT03712072
NCT03712072
Unknown
N/A

Multi-modal Neuroimaging in Children With Cerebral Palsy or Brachial Plexus Birth Palsy to Assess Functional and Anatomical Reorganization in Relation to Sensory and Motor Functions

Boston Children's Hospital1 site in 1 country32 target enrollmentFebruary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Boston Children's Hospital
Enrollment
32
Locations
1
Primary Endpoint
Somatosensory evoked potentials as assessed using MEG
Last Updated
5 years ago

Overview

Brief Summary

The main goal of this study is to identify abnormal functional and anatomical brain reorganization associated with hand, foot, and shoulder function in children (0-18 years old) with cerebral palsy (CP) due to periventricular white matter injury (PV-WMI) or brachial plexus birth palsy (BPBP) using a multi-modal neuroimaging approach.

Detailed Description

This is a non-interventional study designed to assess changes in the sensorimotor cortex of children with CP as a result of PV-WMI and children with BPBP that combines multiple neuroimaging techniques to better visualize the resulting brain reorganization. The study design will be a mixed 3 (group: CP, BPBP, TD) x 2 (hemisphere: more affected, less affected) analysis of variance (ANOVA), with group being a between-subject factor and hemisphere a within-subjects factor. The research study plans to recruit and test 30 children with CP due to PV-WMI, 30 children with BPBP, and 30 aged-matched and typically developing (TD) children aged from 0 to 18 years old. Data from the participants will be collected over the course of four visits: (i) the recording session for the MEG, (ii) the recording session for the EEG, (iii) the MRI scanning session, and (iv) the TMS session. TD, CP, and BPBP subjects will be asked to commit to these visits. The MEG session will last \~3 hours with the actual measurements lasting \~60 minutes, the EEG session will last \~2 hours with the actual measurements lasting \~60 minutes, the MRI visit will last \~1 hour with the actual acquisition scan timing lasting \~30 minutes, and the TMS visit will last \~1 and a half hours with the actual acquisition time lasting \~45 minutes. Depending on the participant, the behavioral tests may be administered during any of the visits that the child is most comfortable and able to perform them.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
August 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christos Papadelis

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Children with Cerebral Palsy should have:
  • An evaluation by a pediatric neurologist with a diagnosis of CP due to PV-WMI,
  • Absence of any genetic syndrome diagnosis,
  • No history of trauma or brain operation,
  • Classified as high-functioning (I or II) at the Gross Motor Function Classification System (GMFCS)
  • Children with Brachial Plexus Birth Palsy should have:
  • An evaluation by a hand and upper extremity surgeon with a diagnosis of BPBP
  • May or may not have undergone primary microsurgical or secondary reconstructive operations prior to this study.
  • Typically Developing children should have:
  • No history of neurological disorder or brain injury.

Exclusion Criteria

  • Children will be excluded if they meet any of the follow criteria, determined via their medical and developmental history:
  • Having a hard time sitting still,
  • Presence of any metal implants,
  • Baclofen pumps,
  • History of traumatic brain injury or brain operation.

Outcomes

Primary Outcomes

Somatosensory evoked potentials as assessed using MEG

Time Frame: Approximately two years

The amplitude of somatosensory evoked fields (in fempto-Tesla) at the peak of the first cortical response after tactile stimulation will be measured and reported for each stimulation site, each hemisphere \& each patient.

Secondary Outcomes

  • Motor evoked amplitude as assessed using MEG(Approximately two years)
  • Somatosensory evoked potentials as assessed using EEG(Approximately two years)
  • Motor evoked potentials as assessed using EEG(Approximately two years)
  • Cortical excitability of motor cortex assessed using TMS(Approximately two years)

Study Sites (1)

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