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Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
75 Years

Inclusion Criteria:

  • Male or female 18-75 years.
  • 1 year post-injury.

  • Non-progressive SCI at C2-C7.
  • Motor Complete ASIA Impairment Scale (A, B).
  • Ventilator dependency with less than 5 cm H20 maximal inspiratory and expiration pressure.
  • Able to attend weekly testing sessions for up to 21 months.
  • 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.
  • Have intact cognitive ability, able to follow commands/voice concerns, and give consent.

Exclusion Criteria:

  • History of severe autonomic dysreflexia
  • Phrenic nerve or diaphragm pacer
  • Phrenic nerve paralysis
  • Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection
  • Clinically significant depression or ongoing drug abuse
  • Received lung surgery or intrinsic lung disease (COPD, acute or chronic lung infection, asthma, emphysema, cystic fibrosis, etc)

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Study Stats
Protocol No.
18-000994
Category
Neurosurgery
Contact
JULIA CHANG
Location
  • UCLA Santa Monica
  • UCLA Torrance
  • UCLA Westwood
For Providers
NCT No.
NCT04883463
For detailed technical eligibility, visit ClinicalTrials.gov.