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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03712072
• Other study ID #: IRB-P00023570
• Status: Active, not recruiting
• Start date: February 1, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 neuroimaging approach.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: August 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brachial Plexus; Injury, Newborn
• Cerebral Palsy
• Paralysis

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Approximately two years
Secondary	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.	Approximately two years
Secondary	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.	Approximately two years
Secondary	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.	Approximately two years