Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy

NCT ID: NCT04882592

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2024-12-01

Brief Summary

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

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Therapeutic Arm

Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy

Group Type EXPERIMENTAL

SCiP

Intervention Type DEVICE

Noninvasive spinal cord neuromodulator

Sham Arm

Sham Stimulation during Activity Based NeuroRehab Therapy

Group Type SHAM_COMPARATOR

SCiP

Intervention Type DEVICE

Noninvasive spinal cord neuromodulator

Interventions

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SCiP

Noninvasive spinal cord neuromodulator

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

* Intramuscular Botox injection in the past 12 months
Minimum Eligible Age

2 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SpineX Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SpineX

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Parag Gad, PhD

Role: CONTACT

4082035061

Facility Contacts

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Parag Gad, PhD

Role: primary

408-203-5061

References

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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.

Reference Type DERIVED
PMID: 36198701 (View on PubMed)

Other Identifiers

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SPNX-00

Identifier Type: -

Identifier Source: org_study_id

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