Multi-modal Neuroimaging in Children With Cerebral Palsy or Brachial Plexus Birth Palsy
1 other identifier
observational
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedAugust 3, 2020
July 1, 2020
3 years
January 24, 2018
July 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Somatosensory evoked potentials as assessed using MEG
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.
Approximately two years
Secondary Outcomes (4)
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 Arms (3)
Children with Cerebral Palsy
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
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
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.
Interventions
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.
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.
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).
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christos Papadelis, PhD
Boston Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 24, 2018
First Posted
October 19, 2018
Study Start
February 1, 2018
Primary Completion
February 1, 2021
Study Completion
August 1, 2021
Last Updated
August 3, 2020
Record last verified: 2020-07