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Neuromodulation Device

Spinal Cord Neuromodulation for Spinal Cord Injury

Phase 1 & 2
Waitlist Available
Led By Daniel C Lu, MD PhD
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
No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery
Non-progressive SCI above C5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a spinal cord stimulator can help people with spinal cord injuries to move better.

Who is the study for?
This trial is for adults over 18 with non-progressive spinal cord injury above C5, at least one year post-injury. Participants should not have severe heart/lung diseases, ongoing depression or drug abuse, recent botox injections, or conditions that prevent arm movement. Pregnant women and those on anti-spasticity meds or involved in other trials are excluded.
What is being tested?
The study tests whether spinal cord stimulation combined with a medication called Buspirone can improve movement in people with quadriplegia due to spinal cord injury. It aims to assess the effectiveness of this neuromodulation strategy.
What are the potential side effects?
Potential side effects may include discomfort from the epidural stimulation device and common reactions to Buspirone like dizziness, nausea, headache, fatigue, and restlessness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have bleeding disorders, heart risks, or major health issues for surgery.
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My spinal cord injury is stable and located above the C5 vertebra.
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My reflexes work below my spinal injury.
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I am not pregnant and use birth control.
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I do not have severe heart or lung diseases.
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I am not currently taking any medication for muscle stiffness.
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It has been over a year since my injury.
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I don't have any unhealed injuries or infections in my arms that would affect training.
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I am 18 years old or older.
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My heart and lungs are healthy enough for me to move my hands and arms without issues.
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I do not have severe heart or lung diseases.
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I cannot grip or move on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of arm/hand function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: StimulationExperimental Treatment2 Interventions
Determine if epidural stimulation can improve motor function.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
2022
Completed Phase 4
~1160

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,564 Previous Clinical Trials
10,262,621 Total Patients Enrolled
1 Trials studying Quadriplegia
2 Patients Enrolled for Quadriplegia
Daniel C Lu, MD PhDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

Epidural Stimulation (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT02313194 — Phase 1 & 2
Quadriplegia Research Study Groups: Stimulation
Quadriplegia Clinical Trial 2023: Epidural Stimulation Highlights & Side Effects. Trial Name: NCT02313194 — Phase 1 & 2
Epidural Stimulation (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02313194 — Phase 1 & 2
~0 spots leftby Dec 2024
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