Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy

SpineX

Status and phase: Enrolling; Phase 1

Conditions: Cerebral Palsy

Treatments: Device: SCiP

Study type: Interventional

Funder types: Industry

Identifiers

NCT04882592

SPNX-00

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Therapeutic Arm

Experimental group

Description:

Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy

Treatment:

Device: SCiP

Sham Arm

Sham Comparator group

Description:

Sham Stimulation during Activity Based NeuroRehab Therapy

Treatment:

Device: SCiP