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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04882592
Other study ID # SPNX-00
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 15, 2021
Est. completion date December 1, 2024

Study information

Verified date March 2023
Source SpineX Inc.
Contact Parag Gad, PhD
Phone 4082035061
Email parag@spinex.co
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
SCiP
Noninvasive spinal cord neuromodulator

Locations

Country Name City State
United States SpineX Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
SpineX Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stepping overground or on a treadmill 3 months
Primary Gross Motor Functional Measure (GMFM) 3 months
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