Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT04883463
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Epidural stimulation — DEVICE
    Epidural electrical stimulation implant weekly sessions for 21 months.

Study Details

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.

Key Dates

Start date
Sep 27, 2021
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Epidural Stimulation for Respiratory Function
    Self-controlled longitudinal safety and feasibility of stimulation and respiratory training.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Semel Institute of Neuroscience at UCLALos AngelesCalifornia90024
Daniel Lu, MD,PhD
mailto:[email protected]
310-267-0149
Sandra Holley, PhD
[email protected]
3102671770
UCLA Clinical and Translational Research CenterLos AngelesCalifornia90095
Daniel Lu, MD
[email protected]
310-267-0149

Find similar trials in Los Angeles, CA

By research site
Semel Institute of Neuroscience at UCLA· Los Angeles, CAUCLA Clinical and Translational Research Center· Los Angeles, CA

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