Actively Recruiting
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
Led by University of California, Los Angeles · Updated on 2025-11-06
12
Participants Needed
2
Research Sites
378 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 1 study of safety and feasibility of cervical spinal cord stimulator implantation in cervical SCI subjects who are ventilator dependent. The Investigators will be focusing on the safety and feasibility of this approach. Participants may qualify for the study if they are male or female 18-75 years old, are at least 1 year after original injury, have injury at C2 to C7 level, and dependent on mechanical ventilation to help them breathe. Additionally, they need to be able to attend up to twice weekly testing sessions for up to 21 months.
CONDITIONS
Official Title
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- At least 1 year since initial cervical spinal cord injury
- Non-progressive spinal cord injury at C2 to C7 levels
- Motor complete injury classified as ASIA Impairment Scale A, B, or C
- Severe respiratory function loss requiring invasive or noninvasive ventilation
- Ability to attend weekly testing sessions for up to 21 months
- Intact chest, lung, upper and lower extremity anatomy with neuromuscular connections intact
- Cognitive ability to follow commands, communicate concerns, and provide consent
You will not qualify if you...
- History of severe autonomic dysreflexia
- Having a phrenic nerve or diaphragm pacer
- Phrenic nerve paralysis
- Musculoskeletal dysfunction, unhealed fractures, or severe pressure ulcers (grade 3 or above)
- Active infection
- Clinically significant depression or ongoing drug abuse
- Lung surgery within the past year or active intrinsic lung disease (e.g., COPD, asthma, emphysema, cystic fibrosis)
- Cardiopulmonary disease preventing training or rehabilitation
- Presence of other implanted stimulation devices
- Pregnancy
- Severe cardiac disease such as heart failure, atherosclerosis, arrhythmia, or stroke
- Participation in other unrelated clinical trials
- Botox injections in respiratory muscles within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Semel Institute of Neuroscience at UCLA
Los Angeles, California, United States, 90024
Actively Recruiting
2
UCLA Clinical and Translational Research Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
D
Daniel C Lu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here