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Neuromodulation Device

Spinal Cord Stimulation for Cerebral Palsy

Phase 1
Recruiting
Research Sponsored by SpineX Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals above the age of 2 years diagnosed with cerebral palsy (CP)
Diagnosis of cerebral palsy (CP)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial is testing whether a noninvasive spinal cord stimulation device can help improve function in people with cerebral palsy.

Who is the study for?
This trial is for people over the age of 2 with cerebral palsy. It's not suitable for those on antispastic meds, who've had certain surgeries like selective dorsal root rhizotomy or tendon lengthening, recent Botox injections in muscles, or unhealed fractures/contractures.Check my eligibility
What is being tested?
The study tests SCiP (Spinal Cord neuromodulation) to see if it can help improve movement and function in individuals with cerebral palsy without needing surgery or drugs.See study design
What are the potential side effects?
Since this involves noninvasive spinal stimulation, potential side effects might include discomfort at the site of stimulation, mild skin irritation from electrode placement, and muscle fatigue after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 2 years old and have been diagnosed with cerebral palsy.
Select...
I have been diagnosed with cerebral palsy.
Select...
I am over 2 years old and have been diagnosed with cerebral palsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gross Motor Functional Measure (GMFM)
Stepping overground or on a treadmill

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Therapeutic ArmExperimental Treatment1 Intervention
Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy
Group II: Sham ArmPlacebo Group1 Intervention
Sham Stimulation during Activity Based NeuroRehab Therapy

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SpineX Inc.Lead Sponsor
2 Previous Clinical Trials
190 Total Patients Enrolled
1 Trials studying Cerebral Palsy
60 Patients Enrolled for Cerebral Palsy

Media Library

SCiP (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04882592 — Phase 1
Cerebral Palsy Research Study Groups: Therapeutic Arm, Sham Arm
Cerebral Palsy Clinical Trial 2023: SCiP Highlights & Side Effects. Trial Name: NCT04882592 — Phase 1
SCiP (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04882592 — Phase 1
Cerebral Palsy Patient Testimony for trial: Trial Name: NCT04882592 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How may I join this clinical trial?

"This research seeks 30 individuals aged between 2 and 75 with cerebral palsy to participate. To be eligible, these persons must have a clinical diagnosis of CP and an age greater than two years old."

Answered by AI

Does this research accommodate seniors above the age of 65?

"This study has a wide age bracket, ranging from 2 to 75 years old. Of the total 166 participants, 140 are juveniles and 26 are in their senior years."

Answered by AI

Are new enrollees accepted for this experiment?

"Data from clinicaltrials.gov confirms that this trial is actively recruiting participants; it was initially published on May 1st 2021, with the latest changes being made on May 6th."

Answered by AI

How many participants are being enlisted in this clinical trial?

"Indeed, the records hosted on clinicaltrials.gov demonstrate that this research trial is actively recruiting subjects. The initial posting occurred on May 1st 2021 and was recently updated last month; 30 volunteers are sought from a single site."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
SpineX
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

We are looking for new technologies to help our son to develop.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
2021. "Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04882592.
All > Cerebral Palsy
~13 spots leftby Apr 2025
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