SBIR-STTR Award

Spinal Cord Innovation in Pediatrics to Treat Cerebral Palsy (SCiP Clinical Study)
Award last edited on: 2/14/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$924,592
Award Phase
1
Solicitation Topic Code
865
Principal Investigator
Parag Gad

Company Information

SpineX Inc

19509 Astor Place
Northridge, CA 91324
   (408) 203-5061
   N/A
   www.spinex.co
Location: Single
Congr. District: 32
County: Los Angeles

Phase I

Contract Number: 2023
Start Date: ----    Completed: 9/22/2023
Phase I year
2023
Phase I Amount
$924,592
Cerebral Palsy (CP) is the most common motor disability in childhood. Population-based studies from around the world report prevalence estimates ranging from 1.5 to 4 per 1000 individuals. Globally, approximately 17 million people have CP. It is a diagnosis that includes a wide range of symptoms with heterogeneous etiologies of neural and cardiovascular origins. A wide range of functional disorders typically become obvious in CP during early development. For example, the majority of children classified as Gross Motor Functional Classification Scale (GMFCS) Level I are expected to reach their motor potential between 7-9 years and remain stable after that until age 21 where they may decline due to pain, weakness and stiffness. While movements such as stepping and posture are amongst the most recognizable impairments, absence or abnormal sensations, perception, impaired cognition, communication skills, epilepsy, spasticity, poor control of fine movements and marked secondary musculoskeletal problems can emerge with time. Presently, all available interventions are designed to minimize the severity of symptoms rather than correcting the neurological etiology. Two commonly preferred treatments, selective dorsal root rhizotomy and repetitive administration of botulinum toxin A (Botox) directly target the neuromuscular system to counter spasticity. While these two strategies minimize some of the disruptive movements associated with spasticity; the long-term benefits of these interventions are less clear and both cause irreversible changes to the neuromuscular system that may be detrimental to future function. In the present proposal we have merged ideas and concepts derived from both recent clinical observations of CP and decades of studies of spinal cord injury to arrive at a subject-specific rehabilitation strategy driven by activity- based mechanisms during transcutaneous spinal neuromodulation. The objectives of our neuromodulation procedures are to amplify the plasticity of the neuromuscular system and help children gain the ability to perform coordinated movements through activity-dependent plasticity. We hypothesized that transcutaneous spinal neuromodulation during activity-based neurorehabilitation therapy (ABNT) can transform the neural networks in children diagnosed with spastic CP to improve voluntary postural and locomotor activity as captured on the GMFM88 scores. This strategy could provide a specific physiological target of fundamental significance in the control of movement that can be used to improve function and provide new care pathways for children with CP.

Public Health Relevance Statement:
Narrative Currently prescribed treatments for children with cerebral palsy are often invasive or make irreversible changes to the neuromuscular system that may have long-term detrimental impacts on function. Noninvasive transcutaneous spinal neuromodulation using SCIPTM device paired with activity-based neurorehabilitation therapy (ABNT) has the potential to improve function and quality of life for children with cerebral palsy .

Project Terms:
21+ years old; Adult Human; adulthood; Adult; Affect; ages; Age; Pain Control; Pain Therapy; pain treatment; Pain management; Neurogenic Bladder; Neurogenic Bladder Disorder; Neurogenic Urinary Bladder Disorder; Neuropathic Bladder; Urinary Bladder Neurogenic Dysfunction; Botulinum Toxin Type A; Botulinum A Toxin; Botulinum Neurotoxin A; Clostridium Botulinum Toxin Type A; Clostridium botulinum A Toxin; botulinum toxin A; Brain; Brain Nervous System; Encephalon; Cardiovascular system; Cardiovascular; Cardiovascular Body System; Cardiovascular Organ System; Heart Vascular; circulatory system; Cerebral Palsy; Child; 0-11 years old; Child Youth; Children (0-21); kids; youngster; Classification; Systematics; Clinical Research; Clinical Study; Communication; Statistical Data Interpretation; Statistical Data Analyses; Statistical Data Analysis; statistical analysis; Diagnosis; Double-Blind Method; Double-Blind Study; Double-Blinded; Double-Masked Method; Double-Masked Study; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Epilepsy; Epileptic Seizures; Epileptics; Seizure Disorder; epilepsia; epileptogenic; Equilibrium; balance; balance function; Feedback; Future; Intramuscular Injections; intramuscular drug administration; Maintenance; Motor Activity; Locomotor Activity; Movement; body movement; Muscle; Muscle Tissue; muscular; Persons; Nervous System Physiology; Neurologic function; Neurological function; nervous system function; Pain; Painful; Parents; parent; Pediatrics; Perception; Pilot Projects; pilot study; Posture; Proprioception; Quality of life; QOL; Risk; Safety; Esthesia; Sensation; Spinal Cord; Medulla Spinalis; Spinal cord injury; Spinal Cord Trauma; Spinal Trauma; Spinal cord injured; Traumatic Myelopathy; Vertebral column; Spinal Column; Spine; backbone; Testing; Time; Measures; Caring; improved; Procedures; Neuro rehabilitation; Neurorehabilitation; neurological rehab; neurorehab; neurorehabilitative; neurological rehabilitation; Clinical; Physiologic; Physiological; Neurological; Neurologic; Dorsal Roots; spinal nerve posterior root; disability; pediatric; Childhood; Muscle function; Individual; Sample Size; Dysfunction; Physiopathology; pathophysiology; Functional disorder; randomized control trial; Randomized, Controlled Trials; Rhizotomy; cutting of spinal nerve root; division of spinal nerve root; incision of spinal nerve root; intraspinal nerve root division; radicotomy; radiculotomy; transection of spinal nerve root; Rhizotomy procedure; Therapeutic; Spastic Cerebral Palsy; Impaired cognition; Cognitive Disturbance; Cognitive Impairment; Cognitive decline; Cognitive function abnormal; Disturbance in cognition; cognitive dysfunction; cognitive loss; Life; Severities; Musculoskeletal; Spinal; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; meetings; meeting; Sensorimotor functions; neuromuscular system; neuromotor system; transcutaneous stimulation; transdermal stimulation; neuroregulation; neural control; neural regulation; neuromodulation; neuromodulatory; neural; skills; Agreement; Population Study; population-based study; population-level study; studies of populations; study of the population; Devices; Reporting; neural circuit; neural circuitry; neurocircuitry; synaptic circuit; synaptic circuitry; response; Intervention; Intervention Strategies; interventional strategy; Physical therapy; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physiotherapy; Causality; causation; disease causation; Etiology; Address; Symptoms; International; Motor; Update; follow-up; Active Follow-up; active followup; follow up; followed up; followup; Development; developmental; symptom management; manage symptom; Pathway interactions; pathway; pilot trial; designing; design; Outcome; Prevalence; aged; prospective; innovate; innovative; innovation; 21 years of age; age 21; age 21 years; twenty-one year old; twenty-one years of age; 21 year old; Impairment; clinical significance; clinically significant; usability; new drug treatments; new drugs; new pharmacological therapeutic; new therapeutics; new therapy; next generation therapeutics; novel drug treatments; novel drugs; novel pharmaco-therapeutic; novel pharmacological therapeutic; novel therapy; novel therapeutics; rehab strategy; rehabilitation strategy; improve function; improved functional outcomes; functional improvement; intervention design; treatment design; therapy design; information processing; primary outcome; secondary outcome; standard of care; sensory input; spasticity; neuromuscular plasticity; recruit; neural network; functional electrostimulation; functional electrical stimulation; Breakthrough device

Phase II

Contract Number: 1R44HD112281-01A1
Start Date: 8/31/2025    Completed: 00/00/00
Phase II year
----
Phase II Amount
----