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Spinal Cord Innovation in Pediatrics (SCiP) to Treat SensoriMotor Function in Children Cerebral Palsy: Protocol for a Randomized Controlled Trial

Primary Purpose

Cerebral Palsy

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCiP
Sponsored by
SpineX Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject is ≥ 2 and ≤ 18 years old at the time of enrollment/consent. Subject has a diagnosis of CP classified as Gross Motor Classification Scale Levels I-V. Minimum score of 12 and Maximum score of 85 on the GMFM-88 total score scale. Subject must have spastic CP hemiplegia or diplegia, quadriplegia. Subject's medical condition is stable as determined by the investigator. Subject has adequate social support network to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator. Subject is capable of performing simple cued motor tasks and can follow 2-3 step commands. Subject can communicate an accurate yes or no answer to questions according to parents. Exclusion Criteria: Subject has a concurrent neurological disease affecting the central nervous system. Subject has implanted stimulator (e.g., epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc.) or drug delivery device (e.g., baclofen pump) Subject is dependent on an electro-magnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or another external device. Subject has received botulinum toxin injection within 12 months preceding enrollment. Subject is unable to participate in ABNT without orthosis. Subject has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that, in the opinion of the investigator, will preclude them from participation and completion of study procedures or requirements. Subject has a medical condition or complications related to the use of certain medications that may affect validity of the study as determined by the investigator. Subject has a medical condition not listed above that may put the subject at risk as determined by the investigator. Subject is participating in or plans to participate in another research study that may interfere with study endpoints. Subject is known or suspected to be non-compliant; and/or subject is unable or unwilling to comply with study requirements. Subject has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention Subject has a history of uncontrolled seizures. Subject has unhealed fracture or other musculoskeletal impairment that might interfere with upper or lower extremity rehabilitation or testing activities. Subject has a history of orthopedic surgery in upper or lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, percutaneous lengthening, spinal fusion etc.) in last 12 months. Subject has a true leg length discrepancy greater than 2 cm. Subject has established osteoporosis and taking medication for osteoporosis treatment. Subject has undergone selective dorsal rhizotomy surgery. Subject has hip or shoulder migration percentage > 30% on anteroposterior radiographic imaging. Subject has less than 20 degrees in hip Range of Motion (ROM) in hip abduction. Subject has unexplained presence of persistent complaints of pain of any kind. Subject has fixed upper or lower extremity contractures of 20 degrees or more. Subject has a fixed spinal scoliosis greater than 20 degrees. Subject has severe cortico-visual impairment. Subject has other ongoing, or who has discontinued less than 14 days prior to consent, physical and occupational therapies including but not limited to robotic therapy, gait training, aqua therapy, hippo therapy, intensive therapies, whole body vibration (WBV), stimulation therapies (e.g., E-Stimulation, Functional Electrical Stimulation (FES), Neuromuscular Electrical Stimulation (NMES)).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Therapeutic Arm

    Sham Arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    GMFM88

    Secondary Outcome Measures

    Modified Ashworth Scale

    Full Information

    First Posted
    January 31, 2023
    Last Updated
    January 31, 2023
    Sponsor
    SpineX Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05720208
    Brief Title
    Spinal Cord Innovation in Pediatrics (SCiP) to Treat SensoriMotor Function in Children Cerebral Palsy: Protocol for a Randomized Controlled Trial
    Official Title
    Spinal Cord Innovation in Pediatrics (SCiP) to Treat SensoriMotor Function in Children Cerebral Palsy: Protocol for a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SpineX Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Cerebral palsy affects up to 4 children in 1000 live births, making it the most common motor disorder in children. It impairs the child's ability to move voluntarily and maintain balance and posture, and resultsing in a wide range of other functional disorders during early development that persist and frequently worsen with age including spasticity and often multiple abnormal sensationsensory modalities. Current standard of care treatments focus on symptom management and do not mitigate the progression of many of these underlying neurological impairments. The goal of this trial is to conduct a prospective multicenter, double-blinded, sham-controlled, crossover, randomized control trial to demonstrate the safety and efficacy of noninvasive spinal cord stimulation (using SCiPTM device, SpineX Inc.) in conjunction with activity-based neurorehabilitation therapy (ABNT) to improve voluntary sensorimotor function in children with cerebral palsy. 44 children participants (aged 2-18 years) diagnosed with CP classified as Gross Motor Function Classification Scale Levels I-V will be recruited and divided equally into two groups (G1 and G2). Both groups will receive identical ABNT 2 days/wk. G1 will initially receive sham stimulation, whereas G2 will receive therapeutic SCiPTM therapy for 8 weeks. After 8 weeks, G1 will cross over and receive therapeutic SCiPTM therapy for 8 weeks, whereas G2 will continue to receive SCiPTM therapy for another 8 weeks, for a total of 16 weeks. Primary and secondary outcome measures will include Gross Motor Function Measure-88 and Modified Ashworth Scale respectively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapeutic Arm
    Arm Type
    Experimental
    Arm Title
    Sham Arm
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    SCiP
    Intervention Description
    Noninvasive Spinal Cord Neuromodulator
    Primary Outcome Measure Information:
    Title
    GMFM88
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Modified Ashworth Scale
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is ≥ 2 and ≤ 18 years old at the time of enrollment/consent. Subject has a diagnosis of CP classified as Gross Motor Classification Scale Levels I-V. Minimum score of 12 and Maximum score of 85 on the GMFM-88 total score scale. Subject must have spastic CP hemiplegia or diplegia, quadriplegia. Subject's medical condition is stable as determined by the investigator. Subject has adequate social support network to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator. Subject is capable of performing simple cued motor tasks and can follow 2-3 step commands. Subject can communicate an accurate yes or no answer to questions according to parents. Exclusion Criteria: Subject has a concurrent neurological disease affecting the central nervous system. Subject has implanted stimulator (e.g., epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc.) or drug delivery device (e.g., baclofen pump) Subject is dependent on an electro-magnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or another external device. Subject has received botulinum toxin injection within 12 months preceding enrollment. Subject is unable to participate in ABNT without orthosis. Subject has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that, in the opinion of the investigator, will preclude them from participation and completion of study procedures or requirements. Subject has a medical condition or complications related to the use of certain medications that may affect validity of the study as determined by the investigator. Subject has a medical condition not listed above that may put the subject at risk as determined by the investigator. Subject is participating in or plans to participate in another research study that may interfere with study endpoints. Subject is known or suspected to be non-compliant; and/or subject is unable or unwilling to comply with study requirements. Subject has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention Subject has a history of uncontrolled seizures. Subject has unhealed fracture or other musculoskeletal impairment that might interfere with upper or lower extremity rehabilitation or testing activities. Subject has a history of orthopedic surgery in upper or lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, percutaneous lengthening, spinal fusion etc.) in last 12 months. Subject has a true leg length discrepancy greater than 2 cm. Subject has established osteoporosis and taking medication for osteoporosis treatment. Subject has undergone selective dorsal rhizotomy surgery. Subject has hip or shoulder migration percentage > 30% on anteroposterior radiographic imaging. Subject has less than 20 degrees in hip Range of Motion (ROM) in hip abduction. Subject has unexplained presence of persistent complaints of pain of any kind. Subject has fixed upper or lower extremity contractures of 20 degrees or more. Subject has a fixed spinal scoliosis greater than 20 degrees. Subject has severe cortico-visual impairment. Subject has other ongoing, or who has discontinued less than 14 days prior to consent, physical and occupational therapies including but not limited to robotic therapy, gait training, aqua therapy, hippo therapy, intensive therapies, whole body vibration (WBV), stimulation therapies (e.g., E-Stimulation, Functional Electrical Stimulation (FES), Neuromuscular Electrical Stimulation (NMES)).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Parag Gad, PhD
    Phone
    408-203-5061
    Email
    info@spinex.co

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Spinal Cord Innovation in Pediatrics (SCiP) to Treat SensoriMotor Function in Children Cerebral Palsy: Protocol for a Randomized Controlled Trial

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