Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.

Details

This study will examine the utility of Abbott neurostimulation devices for restoring therapeutic benefit from neuromodulation therapy. These devices include programming the BurstDR waveform in an enabled implantable pulse generator (IPG), and dorsal root ganglion stimulation (Proclaim DRG). The BurstDR waveform offers a unique mechanism of action that may explain why it can restore efficacy where tonic stimulation has failed. While all forms of SCS activate the lateral pain pathway, which is responsible for the sensory aspects of pain, only BurstDR has been shown to activate the medial pain pathway which is responsible for the affective components. It is this medial activation that may allow BurstDR to succeed despite psychological factors such as catastrophizing and depression. Additionally, it is possible that BurstDR may be less susceptible to habituation because it more closely mimics natural thalamic firing. Several different methods of implementing BurstDR may be included in this investigation to account for a range of possible existing systems and patient needs. It can be implemented by reprogramming a BurstDR-capable device, connecting a BurstDR-capable IPG to existing leads with an adapter or compatible header, or through full system replacement. While traditional SCS applies stimulation to the dorsal horn of the spinal cord, DRG stimulation targets a bundle of sensory nerve cell bodies just outside of the spinal cord known as the dorsal root ganglion. This form of stimulation has been shown to make it easier to achieve pain-paresthesia overlap, provide consistent stimulation irrespective of body position, and produce paresthesia with a lower current than traditional SCS. Using DRG stimulation as a replacement or supplement to SCS may ensure reliable coverage of the entire painful area and improve pain outcomes. This is the first prospective investigation designed to evaluate the effectiveness of Abbott neurostimulation devices for restoring pain relief in patients with waning or failed therapy.

Keywords

Chronic Pain Burst-capable SCS system DRG Stimulator

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patient must provide written informed consent prior to any clinical investigation related procedure.
  2. Patient has a spinal cord stimulator implanted for chronic, intractable pain.
  3. Patient has inadequate pain relief from their current SCS system.
  4. Patient has a pain NRS ≥ 6.
  5. Physician has determined that the patient's original pain is still addressable with neurostimulation.

You CAN'T join if...

  1. Patient is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
  2. Patient is seeking care for a new pain complaint outside of the original indication for SCS.
  3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the clinical investigation or to comply with follow-up requirements.
  4. Physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system.
  5. Patient requires frequent MRI.
  6. Patient is involved in active disability litigation related to their pain or seeking worker's compensation.
  7. Patient is part of a vulnerable population.

Locations

  • UC San Diego Center for Pain Medicine
    La Jolla California 92093 United States
  • Coastal Pain & Spinal Diagnostics Medical Group
    Carlsbad California 92009 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT03908476
Study Type
Interventional
Last Updated