Cerebral PalsyPhase 2NCT05720208
Spinal Cord Innovation in Pediatrics (SCiP) to Treat SensoriMotor Function in Children Cerebral Palsy: Protocol for a Randomized Controlled Trial
A Phase 2 study testing SCiP in people with Cerebral Palsy, run by SpineX Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- SCiP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 2025
- Phase
- Phase 2
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)).
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Cerebral Palsy
- Being tested
- SCiP
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCiPDevice
Noninvasive Spinal Cord Neuromodulator
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Arm | Experimental | Not described Receives: Device: SCiP |
| Sham Arm | Sham comparator | Not described Receives: Device: SCiP |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM88
Measured: 8 weeks
Secondary outcomes (1)
Modified Ashworth Scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpineX Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720208
- Sponsor's protocol ID
- SPNX-02
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Girshin K, Sachdeva R, Cohn R, Gad P, Krassioukov AV, Edgerton VR. sPinal cOrd neUromodulatioN to treat Cerebral palsy in pEdiatrics: POUNCE Multisite Randomized Clinical Trial. Front Neurosci. 2023 Jul 26;17:1221809. doi: 10.3389/fnins.2023.1221809. eCollection 2023.
PubMed 37564370
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Innovation in Pediatrics (SCiP) to Treat SensoriMotor Function in Children Cerebral Palsy: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05720208
- Acronym / sponsor ID
- SPNX-02
- Conditions
- Cerebral Palsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SpineX Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 9 Feb 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Arm | Experimental | Device: SCiP |
| Sham Arm | Sham comparator | Device: SCiP |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
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 |
|---|---|---|
| SCiPNoninvasive Spinal Cord Neuromodulator | Device | Sham Arm, Therapeutic Arm |
Primary outcome
GMFM88
Time frame: 8 weeks
1 secondary outcome
Modified Ashworth Scale
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Derived from this study: PubMed 37564370Girshin K, Sachdeva R, Cohn R, Gad P, Krassioukov AV, Edgerton VR. sPinal cOrd neUromodulatioN to treat Cerebral palsy in pEdiatrics: POUNCE Multisite Randomized Clinical Trial. Front Neurosci. 2023 Jul 26;17:1221809. doi: 10.3389/fnins.2023.1221809. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCiP in people with Cerebral Palsy, run by SpineX Inc..
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 8 inclusion and 24 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 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Parag Gad, PhD (408-203-5061, info@spinex.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMFM88 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05720208, which also lists 1 linked publication.
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 9 Feb 2023.