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Noninvasive 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
SpineX Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts 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

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

First Posted
May 6, 2021
Last Updated
March 30, 2023
Sponsor
SpineX Inc.
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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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