Multi-modal Neuroimaging in Children With Cerebral Palsy or Brachial Plexus Birth Palsy
- Conditions
- Brachial Plexus; Injury, NewbornCerebral Palsy
- Interventions
- Device: Magnetoencephalography (MEG)Device: Electroencephalography (EEG)Device: Transcranial Magnetic Stimulation (TMS)
- Registration Number
- NCT03712072
- Lead Sponsor
- Boston Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children with Cerebral Palsy Electroencephalography (EEG) 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. Children with Cerebral Palsy Transcranial Magnetic Stimulation (TMS) 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. Typically Developing Children Transcranial Magnetic Stimulation (TMS) 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. Children with Cerebral Palsy Magnetoencephalography (MEG) 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. Children with BPBP Transcranial Magnetic Stimulation (TMS) 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. Typically Developing Children Electroencephalography (EEG) 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. Children with BPBP Magnetoencephalography (MEG) 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. Typically Developing Children Magnetoencephalography (MEG) 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. Children with BPBP Electroencephalography (EEG) 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.
- Primary Outcome Measures
Name Time Method Somatosensory evoked potentials as assessed using MEG 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 Outcome Measures
Name Time Method Motor evoked amplitude as assessed using MEG Approximately two years The amplitude of motor evoked fields (in fempto-Tesla) at the peak of the first cortical response after finger movement will be measured and reported for each site, each hemisphere \& each patient.
Somatosensory evoked potentials as assessed using EEG Approximately two years The amplitude of somatosensory evoked potentials (in micro-Volts) at the peak of the first cortical response after tactile stimulation will be measured and reported for each stimulation site, each hemisphere \& each patient.
Motor evoked potentials as assessed using EEG Approximately two years The amplitude of motor evoked potentials (in micro-Volts) at the peak of the first cortical response after finger movement will be measured and reported for each site, each hemisphere \& each patient.
Cortical excitability of motor cortex assessed using TMS Approximately two years The resting motor threshold (Volts/meter) of the primary motor cortex will be measured and reported for each hemisphere \& each participant.
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States