Summary

Eligibility
for people ages 21-85 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Anastasia Keller, PhD (ucsf)Jeannie Bailey, PhD (ucsf)
Headshot of Anastasia Keller
Anastasia Keller
Headshot of Jeannie Bailey
Jeannie Bailey

Description

Summary

As a leading cause of disability worldwide, chronic low back pain (cLBP) represents a significant medical and socioeconomic problem with estimated health care spending of $87 billion/annually. The efficacy of dorsal column electrical stimulation to inhibit pain was first described over 50 years ago. Since then, several large clinical trials have investigated the therapeutic potential of electrical spinal cord stimulation (SCS) and found that over 70% of patients with intractable pain had over 50% pain relief after 1 year of treatment. Thus, SCS is a promising therapeutic intervention that has superior patient outcomes when compared to traditional modalities for the treatment of cLBP. To date, SCS for treatment of cLBP has been delivered via epidural electrodes, requiring neurosurgical implantation. Although, the implantable stimulators have a low rate of adverse events, secondary complications associated with surgical intervention still occur.Transcutaneous spinal cord stimulation (tSCS) is a rapidly developing non invasive neuromodulation technique in the field of spinal cord injury. Its application potentiates lumbosacral spinal cord excitability enabling motor functions, (e.g. independent standing, postural control) in patients with chronic complete motor paralysis. Given that epidural and transcutaneous SCS activate similar neuronal networks, tSCS for cLBP treatment may be advantageous due to its non-invasive nature which may also allow for a mass market production and rapid patient availability if tSCS is proven efficacious. In this pilot study we will establish the feasibility of tSCS to acutely improve patient reported outcomes (pain scores) and several objective measures, including sit-to-stand biomechanics, neurophysiological and neuroimaging outcomes.

Keywords

Chronic Low-back Pain non-invasive, spinal cord stimulation, neuromodulation Back Pain Low Back Pain tSpinalStim sham_tSpinalStim

Eligibility

You can join if…

Open to people ages 21-85

  • Low back pain
  • Able to get in and out of chair unassisted
  • No changes in medication within 2 weeks of study enrollment
  • Stable dose of their medications within 2 weeks of study enrollment

You CAN'T join if...

  • Body Mass Index (BMI) > 28
  • Hardware in the spine from prior surgeries
  • Presence of epidural stimulation leads
  • Presence of any additional neuromuscular pain unrelated to spinal condition
  • Intolerance to any form of electrical stimulation, such as neuromuscular stimulation in the past
  • Lack of perceived endurance to go through multiple experimental assessments in one day/complete the study which may take up to 3 hours
  • Changes in medications within 2 weeks of study enrollment

Location

  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States

Lead Scientists at University of California Health

  • Anastasia Keller, PhD (ucsf)
    Postdoctoral Scholar, Neurological Surgery, School of Medicine. Authored (or co-authored) 8 research publications. Research interests: spinal cord injury · transcutaneous spinal cord stimulation · neuromodulation · neurophysiology · pain neurobiology
  • Jeannie Bailey, PhD (ucsf)
    Jeannie Bailey, PhD, has over a decade of interdisciplinary research experience in orthopaedic health outcomes focused on lumbar spinal conditions and low back pain. Dr. Bailey received her bachelorís degree from the University of California, Berkeley, and her masterís and doctorate degrees from the University of Washington.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05265000
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated