Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

NCT04883463 | Recruiting DMC FDA Device

• 2 other identifiers: 18-000994UH3NS119772
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries

Keywords

Neuromodulation; Respiratory SCI; Implant

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4

  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.

  2.5 years

• Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4

  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.

  2.5 years

• Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4

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

  2.5 years

Secondary Outcomes (5)

• Evaluating Pulmonary Function Throughout the Duration of the Study; 20% increase in minute ventilation.

  2.5 years

• Evaluating Pulmonary Function Throughout the Duration of the Study; 20% increase in minute ventilation.

  2.5 years

• Evaluating Pulmonary Function Throughout the Duration of the Study; 20%

  2.5 years

• Evaluating Pulmonary Function Throughout the Duration of the Study; 20%

  2.5 years

• Evaluating Pulmonary Function Throughout the Duration of the Study; 20%

  2.5 years

Study Arms (1)

Epidural Stimulation for Respiratory Function

EXPERIMENTAL

Self-controlled longitudinal safety and feasibility of stimulation and respiratory training.

Device: Epidural stimulation

Interventions

Epidural stimulation DEVICE

Epidural electrical stimulation implant weekly sessions for 21 months.

Epidural Stimulation for Respiratory Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18-75 years
• At least 1 year from initial cervical spinal cord injury
• Non-progressive Spinal Cord Injury (SCI) at C2 - C7 (non-conus injury)
• Motor Complete ASIA Impairment Scale (A, B, or C)
• Severe respiratory function compromise requiring dependency on invasive or noninvasive ventilation
• 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

You may not qualify if:

• History of severe autonomic dysreflexia
• Phrenic nerve or diaphragm pacer
• Phrenic nerve paralysis
• Musculoskeletal dysfunction, unhealed fracture, pressure ulcer of grade 3 and above in the European Pressure Ulcer Advisory Panel Grading System, active infection
• Clinically significant depression or ongoing drug abuse as documented in the medical record
• Received lung surgery within one year prior to study enrollment or has active intrinsic lung disease (e.g. COPD, acute or chronic lung infection, moderate to severe asthma, emphysema, cystic fibrosis, etc.)
• Cardiopulmonary disease that precludes training or rehabilitation
• Other implanted stimulation devices
• Pregnant
• Severe cardiac disease (e.g. heart failure, atherosclerosis, arrhythmia, stroke, etc.)
• Subjects involved in other clinical trials not associated with this trial
• Botox injections in respiratory associated muscles within the last 3 months

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Semel Institute of Neuroscience at UCLA

Los Angeles, California, 90024, United States

RECRUITING

UCLA Clinical and Translational Research Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Daniel C Lu, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel C Lu, MD, PhD

CONTACT

310-267-2975; DCLu@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: May 12, 2021
• Study Start: September 27, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (2)