Recruiting

Neuromodulation

Sponsor:

UCLA

Code:

NCT04883463

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Epidural stimulation

Study Details

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

Study ID

NCT04883463

Start date

Sep 27, 2021

Status verified date

Nov, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female 18-75 years
2. At least 1 year from initial cervical spinal cord injury
3. Non-progressive Spinal Cord Injury (SCI) at C2 - C7 (non-conus injury)
4. Motor Complete ASIA Impairment Scale (A, B, or C)
5. Severe respiratory function compromise requiring dependency on invasive or noninvasive ventilation
6. Able to attend weekly testing sessions for up to 21 months.
7. 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
8. Have intact cognitive ability, able to follow commands/voice concerns, and give consent

Exclusion Criteria:

1. History of severe autonomic dysreflexia
2. Phrenic nerve or diaphragm pacer
3. Phrenic nerve paralysis
4. Musculoskeletal dysfunction, unhealed fracture, pressure ulcer of grade 3 and above in the European Pressure Ulcer Advisory Panel Grading System, active infection
5. Clinically significant depression or ongoing drug abuse as documented in the medical record
6. 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.)
7. Cardiopulmonary disease that precludes training or rehabilitation
8. Other implanted stimulation devices
9. Pregnant
10. Severe cardiac disease (e.g. heart failure, atherosclerosis, arrhythmia, stroke, etc.)
11. Subjects involved in other clinical trials not associated with this trial
12. Botox injections in respiratory associated muscles within the last 3 months

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Epidural Stimulation for Respiratory Function

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

Interventions

Epidural stimulation

Epidural electrical stimulation implant weekly sessions for 21 months.

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4 [ Time Frame: 2.5 years ]
  • Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4 [ Time Frame: 2.5 years ]
  • Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4 [ Time Frame: 2.5 years ]

Central Contacts and Locations

Central contacts

Locations

Semel Institute of Neuroscience at UCLA

Recruiting

Los Angeles, California, United States, 90024

Contacts

UCLA Clinical and Translational Research Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

More Information

Sponsor

University of California, Los Angeles

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Keywords

  • Neuromodulation
  • Respiratory SCI
  • Implant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-11-06.