Cerebral PalsyNCT03712072
Multi-modal Neuroimaging in Children With Cerebral Palsy or Brachial Plexus Birth Palsy
An observational study of Cerebral Palsy and Brachial Plexus; Injury, Newborn, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Brachial Plexus; Injury, Newborn
- What is being tested?
- Magnetoencephalography (MEG), Electroencephalography (EEG) and Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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
- Being tested
- Magnetoencephalography (MEG), Electroencephalography (EEG), Transcranial Magnetic Stimulation (TMS)
- Medical subject headings
- Cerebral Palsy, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetoencephalography (MEG)Device
Also called MagView Biomagnetometer
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.
Electroencephalography (EEG)Device
Also called Waveguard (TM) EEG cap
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.
Transcranial Magnetic Stimulation (TMS)Device
Also called Nexstim Navigated Brain Stimulation (NBS) System 4
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Magnetoencephalography (MEG); Device: Electroencephalography (EEG); Device: Transcranial Magnetic Stimulation (TMS) | |
| 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. Receives: Device: Magnetoencephalography (MEG); Device: Electroencephalography (EEG); Device: Transcranial Magnetic Stimulation (TMS) | |
| 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. Receives: Device: Magnetoencephalography (MEG); Device: Electroencephalography (EEG); Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately two years
Secondary outcomes (4)
Motor evoked amplitude as assessed using MEG
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.
Measured: Approximately two years
Somatosensory evoked potentials as assessed using EEG
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.
Measured: Approximately two years
Motor evoked potentials as assessed using EEG
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.
Measured: Approximately two years
Cortical excitability of motor cortex assessed using TMS
The resting motor threshold (Volts/meter) of the primary motor cortex will be measured and reported for each hemisphere \& each participant.
Measured: Approximately two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Feb 2018
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Papadelis, Boston Children's Hospital
- Investigators
- Christos Papadelis, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712072
- Sponsor's protocol ID
- IRB-P00023570
- Status last verified
- Jul 2020
- First submitted
- 24 Jan 2018
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03712072
- Acronym / sponsor ID
- IRB-P00023570
- Conditions
- Cerebral Palsy, Brachial Plexus; Injury, Newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral Palsy | – | Device: Magnetoencephalography (MEG), Device: Electroencephalography (EEG), Device: 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. |
| Children with BPBP | – | Device: Magnetoencephalography (MEG), Device: Electroencephalography (EEG), Device: 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 | – | Device: Magnetoencephalography (MEG), Device: Electroencephalography (EEG), Device: 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (10 listed)
- 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.
- An evaluation by a hand and upper extremity surgeon with a diagnosis of BPBP
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetoencephalography (MEG)Also: MagView BiomagnetometerThe 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 | Children with BPBP, Children with Cerebral Palsy, Typically Developing Children |
| Electroencephalography (EEG)Also: Waveguard (TM) EEG capThe 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 | Children with BPBP, Children with Cerebral Palsy, Typically Developing Children |
| Transcranial Magnetic Stimulation (TMS)Also: Nexstim Navigated Brain Stimulation (NBS) System 4The 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). | Device | Children with BPBP, Children with Cerebral Palsy, Typically Developing Children |
Primary outcome
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.
4 secondary outcomes
Motor evoked amplitude as assessed using MEG
Time frame: Approximately two years
Somatosensory evoked potentials as assessed using EEG
Time frame: Approximately two years
Motor evoked potentials as assessed using EEG
Time frame: Approximately two years
Cortical excitability of motor cortex assessed using TMS
Time frame: Approximately two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christos Papadelis, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Brachial Plexus; Injury, Newborn, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatosensory evoked potentials as assessed using MEG (time frame: Approximately two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.