Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04883463
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : November 24, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Daniel Lu, MD, PhD, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Epidural stimulation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
Actual Study Start Date : September 27, 2021
Estimated Primary Completion Date : January 4, 2026
Estimated Study Completion Date : January 4, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Epidural Stimulation for Respiratory Function
Self-controlled longitudinal safety and feasibility of stimulation and respiratory training.
Device: Epidural stimulation
Epidural electrical stimulation implant weekly sessions for 21 months.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4 [ Time Frame: 2.5 years ]
    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. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4 [ Time Frame: 2.5 years ]
    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.

  3. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4 [ Time Frame: 2.5 years ]
    Blood Pressure (mm/Hg): Timeframe: completed at the beginning and end of each testing session.


Secondary Outcome Measures :
  1. Evaluating Pulmonary Function Throughout the Duration of the Study; 20% increase in minute ventilation. [ Time Frame: 2.5 years ]
    Tidal Volume = mL Timeframe: assessed weekly through the duration of the study.

  2. Evaluating Pulmonary Function Throughout the Duration of the Study; 20% increase in minute ventilation. [ Time Frame: 2.5 years ]
    Maximal Expiratory Pressure = cmH2O Timeframe: assessed weekly through the duration of the study.

  3. Evaluating Pulmonary Function Throughout the Duration of the Study; 20% [ Time Frame: 2.5 years ]
    Functional Residual Capacity = mL/kg Timeframe: assessed weekly through the duration of the study.

  4. Evaluating Pulmonary Function Throughout the Duration of the Study; 20% [ Time Frame: 2.5 years ]
    Peak Expiratory Flow Rate = mL/min Timeframe: assessed weekly through the duration of the study.

  5. Evaluating Pulmonary Function Throughout the Duration of the Study; 20% [ Time Frame: 2.5 years ]
    Minute Volume (measured in L/min): Timeframe: assessed weekly through the duration of the study. Data for all of the assessments mentioned above will be analyzed to compare each individual's function to their own at the beginning of the study, during the baseline period.Electromyography (EMG): Respiratory muscle activity will be assessed with common practice EMG recording and functional measurements. Timeframe: assessed weekly through the duration of the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 18-75 years.
  2. > 1 year post-injury.
  3. Non-progressive SCI at C2-C7.
  4. Motor Complete ASIA Impairment Scale (A, B).
  5. Ventilator dependency with less than 5 cm H20 maximal inspiratory and expiration pressure.
  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, active infection
  5. Clinically significant depression or ongoing drug abuse
  6. Received lung surgery or intrinsic lung disease (COPD, acute or chronic lung infection, asthma, emphysema, cystic fibrosis, etc)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04883463


Contacts
Layout table for location contacts
Contact: Daniel C Lu, MD, PhD 310-267-2975 DCLu@mednet.ucla.edu

Locations
Layout table for location information
United States, California
Semel Institute of Neuroscience at UCLA Recruiting
Los Angeles, California, United States, 90024
Contact: Daniel Lu, MD    310-267-0149    mailto:DCLu@mednet.ucla.edu   
Contact: Julia Chang, PhD    310-267-0149    jwchang@mednet.ucla.edu   
UCLA Clinical and Translational Research Center Recruiting
Los Angeles, California, United States, 90095
Contact: Daniel Lu, MD    310-267-0149    DCLu@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Daniel C Lu, MD, PhD University of California, Los Angeles
Layout table for additonal information
Responsible Party: Daniel Lu, MD, PhD, Associate Professor of Neurosurgery, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04883463    
Other Study ID Numbers: 18-000994
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Daniel Lu, MD, PhD, University of California, Los Angeles:
Neuromodulation
Respiratory SCI
Implant
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System