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Neuromodulation for Respiratory Function in Spinal Cord Injury

This study is exploring a treatment called epidural electrical stimulation for people with cervical spinal cord injuries (SCI) who need help breathing. The researchers want to see if this treatment is safe and practical. You might be able to join if you are 18-75 years old, had your SCI at least a year ago, your injury is between C2 and C7, and you rely on a ventilator to breathe. The study involves implanting a device for epidural electrical stimulation and attending weekly sessions for up to 21 months. The main goal is to track any side effects (adverse events) from the treatment over 2.5 years. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 12 participants. It focuses on the safety and feasibility of epidural electrical stimulation.
What's involved
You would undergo baseline testing for up to 6 months, followed by temporary and then permanent device implantation. You would attend up to twice-weekly testing sessions for up to 21 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2.5 years to assess any treatment-emergent adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04883463

Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Recruiting
NAAges 18–75InterventionalTreatment
University of California, Los Angeles
~12 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:Epidural stimulation

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4
Measured over 2.5 years
+2 more outcomes measured

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Daniel C Lu, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

Who to contact

Daniel C Lu, MD, PhD
[email protected]
310-267-2975
Email the study team

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What this trial measures

  • Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v42.5 years

    International Standards for Neurological Classification of Spinal Cord Injury/American Spinal Injury Association (ISNCSCI/ASIA)- Neurological motor and sensory function given a score A-E: Timeframe: completed at the beginning and end of the phases.

  • Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v42.5 years

    Resting Spontaneous Respiratory Activity (measured in Breathes per Minute), Maximal Inspiratory Pressure (measured in cmH2O) and Spinal Cord Independence Measure (a score from 0-100) questionnaire: Timeframe: assessed weekly through the duration of the study. Data will be analyzed to compare each individual's function to their own at the beginning of the study, during the baseline period.

  • Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v42.5 years

    Blood Pressure (mm/Hg): Timeframe: completed at the beginning and end of each testing session.