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Multi-modal Neuroimaging in Children With Cerebral Palsy or Brachial Plexus Birth Palsy

Boston Children's Hospital logo

Boston Children's Hospital

Status

Unknown

Conditions

Brachial Plexus; Injury, Newborn
Cerebral Palsy

Treatments

Device: Electroencephalography (EEG)
Device: Magnetoencephalography (MEG)
Device: Transcranial Magnetic Stimulation (TMS)

Study type

Observational

Funder types

Other

Identifiers

NCT03712072
IRB-P00023570

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

Under 18 years old

Volunteers

Accepts Healthy Volunteers

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)32.

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.

Trial design

32 participants in 3 patient groups

Children with Cerebral Palsy
Description:
Data from the participants with Cerebral Palsy will be collected over the course of four visits: (i) the recording session for the Magnetoencephalography (MEG), (ii) the recording session for the Electroencephalography (EEG), (iii) the Magnetic Resonance Imaging (MRI) scanning session, and (iv) the Transcranial Magnetic Stimulation (TMS) session.
Treatment:
Device: Transcranial Magnetic Stimulation (TMS)
Device: Magnetoencephalography (MEG)
Device: Electroencephalography (EEG)
Children with BPBP
Description:
Data from the participants with Brachial Plexus Birth Palsy will be collected over the course of four visits: (i) the recording session for the Magnetoencephalography (MEG), (ii) the recording session for the Electroencephalography (EEG), (iii) the Magnetic Resonance Imaging (MRI) scanning session, and (iv) the TMS session.
Treatment:
Device: Transcranial Magnetic Stimulation (TMS)
Device: Magnetoencephalography (MEG)
Device: Electroencephalography (EEG)
Typically Developing Children
Description:
Data from the typically developing participants will be collected over the course of four visits: (i) the recording session for the Magnetoencephalography (MEG), (ii) the recording session for the Electroencephalography (EEG), (iii) the Magnetic Resonance Imaging (MRI) scanning session, and (iv) the Transcranial Magnetic Stimulation (TMS) session.
Treatment:
Device: Transcranial Magnetic Stimulation (TMS)
Device: Magnetoencephalography (MEG)
Device: Electroencephalography (EEG)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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