RECRUITING

Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Talk to us

Conditions

Spinal Cord InjuriesNeuromodulationRespiratory SCIImplant

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Quick Facts

Study Start:2021-09-27
Study Completion:2027-01-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04883463

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or Female Age 18-75.
  2. 2. Diagnosed with cervical spinal cord injury (SCI).
  3. 3. At least 1 year from initial spinal cord injury.
  4. 4. Severe respiratory function compromise.
  5. 5. Able to attend weekly testing sessions for up to 21 months.
  6. 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. 7. Have intact cognitive ability, able to follow commands/voice concerns, and give consent.
  1. 1. History of severe autonomic dysreflexia.
  2. 2. Phrenic nerve or diaphragm pacer.
  3. 3. Phrenic nerve paralysis.
  4. 4. Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection.
  5. 5. Clinically significant depression or ongoing drug abuse.
  6. 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).

Contacts and Locations

Study Contact

Daniel C Lu, MD, PhD
CONTACT
310-267-2975
DCLu@mednet.ucla.edu

Principal Investigator

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

Study Locations (Sites)

Semel Institute of Neuroscience at UCLA
Los Angeles, California, 90024
United States
UCLA Clinical and Translational Research Center
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-27
Study Completion Date2027-01-04

Study Record Updates

Study Start Date2021-09-27
Study Completion Date2027-01-04

Terms related to this study

Keywords Provided by Researchers

  • Neuromodulation
  • Respiratory SCI
  • Implant

Additional Relevant MeSH Terms

  • Spinal Cord Injuries