NCT03712072

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cerebral Palsy
• Brachial Plexus; Injury, Newborn

Interventions

Type	Name	Description
DEVICE	Magnetoencephalography (MEG)	The purpose of the device is to measure magnetic fields produced by an individual's brain and provide information on the location of the source of the fields. Participants between the ages of 0-3 years of old whose head can fit in the MEG helmet will be the patient population used for the BabyMEG. The device will be used in this study to learn more about the somatosensory and motor networks of children who have cerebral palsy and compare their brain signals to healthy children.
DEVICE	Electroencephalography (EEG)	The device is an EEG cap - a non-invasive EEG positioning system used to quickly place a large number of surface electrodes in a quick and consistent manner on the head. The device will measure electrophysiological signals from the scalp.
DEVICE	Transcranial Magnetic Stimulation (TMS)	The device will be used for motor mapping. Motor threshold is operationally defined as minimum machine output necessary to elicit a response from the abductor pollicis brevis right (APB), contralateral to the stimulated hemisphere, of 50 microvolts, on \>50% of trials. Upper limb motor mapping is conducted at 110% abductor pollicis brevis motor threshold in each hemisphere, or at 100% machine output (MO). Lower limb motor mapping is conducted at a fixed machine output corresponding to the magnitude sufficient to elicit reliable tibialis anterior (TA) motor evoked potentials (MEPs). Single pulse TMS is performed while motor evoked potentials are recorded bilaterally from the APB, deltoid, and TA using surface electromyography (EMG).

Timeline

• Start date: 2018-02-01
• Primary completion: 2021-02-01
• Completion: 2021-08-01
• First posted: 2018-10-19
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States