Clinical trial NCT03712072: Multi-modal Neuroimaging in Children With Cerebral Palsy or Brachial Plexus Birth Palsy
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Brachial Plexus; Injury, Newborn
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 32
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

The investigators plan 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

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.

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)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.

Primary outcomes:
measure: Somatosensory evoked potentials as assessed using MEG
timeFrame: Approximately two years
Secondary outcomes:
measure: Motor evoked amplitude as assessed using MEG
timeFrame: Approximately two years
measure: Somatosensory evoked potentials as assessed using EEG
timeFrame: Approximately two years
measure: Motor evoked potentials as assessed using EEG
timeFrame: Approximately two years
measure: Cortical excitability of motor cortex assessed using TMS
timeFrame: Approximately two years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Christos Papadelis, PhD
role: PRINCIPAL_INVESTIGATOR
References: