NCT04882592

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

May 6, 2021

Last Update Submit

March 30, 2023

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • Stepping overground or on a treadmill

    3 months

  • Gross Motor Functional Measure (GMFM)

    3 months

Study Arms (2)

Therapeutic Arm

EXPERIMENTAL

Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy

Device: SCiP

Sham Arm

SHAM COMPARATOR

Sham Stimulation during Activity Based NeuroRehab Therapy

Device: SCiP

Interventions

SCiPDEVICE

Noninvasive spinal cord neuromodulator

Sham ArmTherapeutic Arm

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Intramuscular Botox injection in the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SpineX

Los Angeles, California, 90064, United States

RECRUITING

Related Publications (1)

  • Hastings S, Zhong H, Feinstein R, Zelczer G, Mitrovich C, Gad P, Edgerton VR. A pilot study combining noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children with cerebral palsy. Nat Commun. 2022 Oct 5;13(1):5660. doi: 10.1038/s41467-022-33208-w.

    PMID: 36198701DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Parag Gad, PhD

CONTACT

4082035061parag@spinex.co

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 12, 2021

Study Start

May 15, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)