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

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ClinicalTrials.gov Identifier: NCT03712072
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Christos Papadelis, 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.

Condition or disease Intervention/treatment
Cerebral Palsy Brachial Plexus; Injury, Newborn Device: Magnetoencephalography (MEG) Device: Electroencephalography (EEG) Device: Transcranial Magnetic Stimulation (TMS)

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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.
Other Name: MagView Biomagnetometer

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.
Other Name: Waveguard (TM) EEG cap

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).
Other Name: Nexstim Navigated Brain Stimulation (NBS) System 4

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.
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.
Other Name: MagView Biomagnetometer

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.
Other Name: Waveguard (TM) EEG cap

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).
Other Name: Nexstim Navigated Brain Stimulation (NBS) System 4

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.
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.
Other Name: MagView Biomagnetometer

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.
Other Name: Waveguard (TM) EEG cap

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).
Other Name: Nexstim Navigated Brain Stimulation (NBS) System 4




Primary Outcome Measures :
  1. Somatosensory evoked potentials as assessed using MEG [ Time Frame: 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 :
  1. Motor evoked amplitude as assessed using MEG [ Time Frame: 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.

  2. Somatosensory evoked potentials as assessed using EEG [ Time Frame: 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.

  3. Motor evoked potentials as assessed using EEG [ Time Frame: 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.

  4. Cortical excitability of motor cortex assessed using TMS [ Time Frame: Approximately two years ]
    The resting motor threshold (Volts/meter) of the primary motor cortex will be measured and reported for each hemisphere & each participant.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712072


Contacts
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Contact: Christos Papadelis, PhD 781-216-1128 Christos.Papadelis@childrens.harvard.edu
Contact: Vanessa Young, RN, BA 617-355-8330 vanessa.young@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christos Papadelis, PhD    781-216-1128    christos.papadelis@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Christos Papadelis, PhD Boston Children’s Hospital

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Responsible Party: Christos Papadelis, Principal Investigator, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03712072     History of Changes
Other Study ID Numbers: IRB-P00023570
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases