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Neuromodulation Device

Neuromodulation for Spinal Cord Injury

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have intact lower extremity anatomy and able to use lower extremity for assistive standing and stepping
Non-progressive SCI at C2-T8 (non-conus injury)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1-48
Awards & highlights

Study Summary

This trial will investigate if it is safe and helpful to use spinal cord neuromodulation to improve urinary bladder function for people with spinal cord injury.

Who is the study for?
This trial is for males aged 18-45 with spinal cord injury (SCI) at least one year post-injury, who have complete motor SCI (ASIA A or B), and need catheterization for bladder control. Participants must be able to attend sessions twice a week for six months, have non-progressive SCI between C2-T8, and use their lower extremities for standing/stepping assistance.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of electromagnetic neuromodulation in improving urinary bladder function among individuals with spinal cord injuries.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort or skin irritation from the device, muscle spasms due to neuromodulation, or other unforeseen reactions related to the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stand and step using my legs.
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My spinal cord injury is stable and located between my neck and mid-back.
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I can attend testing sessions twice a week for 6 months.
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I am a man aged between 18 and 45.
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I use a catheter periodically due to bladder issues.
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It has been over a year since my injury.
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I have complete motor paralysis according to ASIA A or B.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1-48
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1-48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urine flow and volume

Trial Design

3Treatment groups
Experimental Treatment
Group I: Stimulation of Non-NaiveExperimental Treatment1 Intervention
Evaluate neuromodulation in 6 subjects with prior motor training.
Group II: Stimulation of NaiveExperimental Treatment1 Intervention
Evaluate neuromodulation in 6 naive subjects.
Group III: StimulationExperimental Treatment1 Intervention
Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,279,714 Total Patients Enrolled

Media Library

Electromagnetic Neuromodulation (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT02331979 — N/A
Spinal Cord Injury Research Study Groups: Stimulation of Non-Naive, Stimulation of Naive, Stimulation
Spinal Cord Injury Clinical Trial 2023: Electromagnetic Neuromodulation Highlights & Side Effects. Trial Name: NCT02331979 — N/A
Electromagnetic Neuromodulation (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02331979 — N/A

Frequently Asked Questions

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

Are people of advanced age allowed to participate in this endeavor?

"Eligibility for this research project is limited to individuals aged 18-45."

Answered by AI

Is it possible to register for this experiment?

"Eligible participants for this trial must have suffered a spinal cord injury and fall within the age range of 18-45. So far, 24 patients are slated to join the study."

Answered by AI

What is the approximate scope of participants for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the study is still recruiting participants who were first invited on September 1st 2015 and was most recently updated on May 17th 2023. The team wishes to recruit 24 patients from a single site for this trial."

Answered by AI

Are there any open slots still available for participants in this experiment?

"That is correct. The clinicaltrials.gov website details that this medical trial was initially posted on September 1st, 2015 and recently updated on May 17th, 2023. 24 participants are expected to be recruited from a single location for the study's duration."

Answered by AI

Who else is applying?

What site did they apply to?
University of California, Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Mar 2024