Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Description

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

Spinal Cord Injuries

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Study Overview

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Study Details

Study overview

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.

Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Semel Institute of Neuroscience at UCLA, Los Angeles, California, United States, 90024

Los Angeles

UCLA Clinical and Translational Research Center, Los Angeles, California, United States, 90095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or Female Age 18-75.
  • 2. Diagnosed with cervical spinal cord injury (SCI).
  • 3. At least 1 year from initial spinal cord injury.
  • 4. Severe respiratory function compromise.
  • 5. Able to attend weekly testing sessions for up to 21 months.
  • 6. Have intact chest/lung, upper and lower extremity anatomy. The neuromuscular connections between the spinal cord and its effector muscles (respiratory and extremity) are required to be intact.
  • 7. Have intact cognitive ability, able to follow commands/voice concerns, and give consent.
  • 1. History of severe autonomic dysreflexia.
  • 2. Phrenic nerve or diaphragm pacer.
  • 3. Phrenic nerve paralysis.
  • 4. Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection.
  • 5. Clinically significant depression or ongoing drug abuse.
  • 6. Received lung surgery within one year prior to study enrollment or active intrinsic lung disease (COPD, acute or chronic lung infection, asthma, emphysema, cystic fibrosis, etc).

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

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

Study Record Dates

2027-01-04