Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy

Phase 1

Recruiting

• Conditions: Cerebral Palsy
• Interventions: Device: SCiP

• Registration Number: NCT04882592
• Lead Sponsor: SpineX Inc.

Brief Summary

Assessing the effects of noninvasive spinal cord neuromodulation on improving function in individuals with cerebral palsy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Study Start: 2021-05-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-04
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1. individuals above the age of 2 years of age and 2) diagnosed with cerebral palsy (CP). The exclusion criteria included 1) children with selective dorsal root rhizotomy, 2) intramuscular Botox injection in the preceding 12 months, 3) current antispastic medications 4) unhealed fractures or contractures that would prevent them from performing functional tasks and 5) tendon lengthening surgeries.

Exclusion Criteria

• Intramuscular Botox injection in the past 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Therapeutic Arm	SCiP	Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy
Sham Arm	SCiP	Sham Stimulation during Activity Based NeuroRehab Therapy

Primary Outcome Measures

Name	Time	Method
Gross Motor Functional Measure (GMFM)	3 months
Stepping overground or on a treadmill	3 months

Trial Locations

Locations (1)

SpineX; 🇺🇸 Los Angeles, California, United States