Back to resultsNoninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SCiP
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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
Sites / Locations
- SpineXRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Therapeutic Arm
Sham Arm
Arm Description
Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy
Sham Stimulation during Activity Based NeuroRehab Therapy
Outcomes
Primary Outcome Measures
Stepping overground or on a treadmill
Gross Motor Functional Measure (GMFM)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04882592
Brief Title
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
Official Title
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SpineX Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessing the effects of noninvasive spinal cord neuromodulation on improving function in individuals with cerebral palsy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Arm
Arm Type
Experimental
Arm Description
Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy
Arm Title
Sham Arm
Arm Type
Sham Comparator
Arm Description
Sham Stimulation during Activity Based NeuroRehab Therapy
Intervention Type
Device
Intervention Name(s)
SCiP
Intervention Description
Noninvasive spinal cord neuromodulator
Primary Outcome Measure Information:
Title
Stepping overground or on a treadmill
Time Frame
3 months
Title
Gross Motor Functional Measure (GMFM)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parag Gad, PhD
Phone
4082035061
Email
parag@spinex.co
Facility Information:
Facility Name
SpineX
City
Los Angeles
State/Province
California
ZIP/Postal Code
90064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parag Gad, PhD
Phone
408-203-5061
Email
parag@spinex.co
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
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