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CompletedNCT03954080Updated Apr 5, 2022

Trialing of ISS in Patients With CRPS

An interventional study of Intraspinal-optimal stim therapy in CRPS I and Causalgia, sponsored by Millennium Pain Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Millennium Pain Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2022, 4 years 6 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a multi-center, prospective, open-label, single-arm, observational, feasibility study. The goal of this study is to determine the feasibility of intra-spinal stimulation with optimal paresthesia coverage therapy for chronic pain relief in patients with complex regional pain syndrome type I or causalgia. Up to 20 patients with intractable chronic severe limb pain associated with complex regional pain syndrome (CRPS) will be included in the study. A standard of care trial phase to test a subjects' response to Intraspinal-Optimal Stim therapy will be conducted during a 3 to 10-day period. Patients that obtain 50% or greater pain relief during the trial period will undergo permanent implantation of the device. Primary outcome will evaluate pain response at 3 months of therapy, based on NPRS pain score relative to baseline. Patients will be followed up for 6 months after the start of therapy.

02

Conditions studied

  • CRPS I
  • Causalgia
03

In context

Lead sponsor

Millennium Pain Center is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Capable of giving written informed consent to participate in this clinical study.
  2. Must be 18 years old or older.
  3. Predominant pain in one or both of the lower limbs attributed to CRPS or causalgia that has been refractory to conservative therapy for at least 3 months.
  4. Average pain intensity larger or equal to 6 on the numeric pain rating scale (NPRS).
  5. Appropriate candidate for spinal cord stimulation as determined by the Investigator.
  6. Subjects must be on a stable dose of pain medication regimen for at least 1 month.
  7. Must be able to comply with the requirements of study visits.
  8. Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians.

Exclusion criteria

Exclusion Criteria:

  1. Systemic infection.
  2. Any other active implanted device.
  3. Evidence of serious neurological, psychological or psychiatric disorders.
  4. Previous posterior decompressive laminectomy that precludes appropriate posterior epidural placement of stimulation lead(s).
  5. Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
  6. Human immunodeficiency virus (HIV) infection or a clinically significant infection.
  7. A clinically significant disorder such as cerebrovascular disease, pulmonary infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or congestive heart failure or any other as determined by the investigator.
  8. Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
  9. Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
  10. Patients who have progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, acute herniated disc, or any other as determined by investigator.
  11. Medical condition or pain in other body areas determined by the Investigator as interfering with study procedures, accurate pain reporting, and/or confound evaluation of study end points.
  12. Concurrent participation in another clinical study.
  13. Involvement in an injury or disability claim under current litigation or a pending or approved workers' compensation claim.
  14. Escalating or changing pain condition over the last 30 days that creates difficulty of pain evaluation by the patient.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    ISS

    Device: Intraspinal-optimal stim therapy

Interventions

  • DeviceIntraspinal-optimal stim therapy

    During the trial, percutaneous lead(s) will be implanted, following standard clinical practices, in the posterior epidural space with the final lead position located in the optimal area to provide pain relief by stimulating neural tissue in order to create paresthesia(s) only on the painful dermatome(s). During Intraspinal-Optimal Stim, a set of electrodes in the stimulation lead(s) will deliver a charge-balanced, pulsed electrical signal with stimulation parameters (frequency, pulse width, and amplitude) within the FDA approved specifications of the commercially available external neurostimulator. These will be adjusted to produce paresthesia coverage of the painful area. Patients that will report equal or greater than 50% reduction in pain, relative to baseline pain, may undergo permanent implantation of a commercially available neurostimulator (INS). This will require a surgical intervention to implant stimulation leads, INS and anchoring hardware followed by therapy programming.

06

What researchers measure

Primary outcomes

  1. Change in pain relative to baseline pain (i.e. prior to therapy) at 3 months after device activation for providing Intraspinal-Optimal Stim therapy

    Change in pain relative to baseline pain (i.e. prior to therapy) at 3 months after device activation for providing Intraspinal-Optimal Stim therapy. Pain scoring will be based on the 11-points (0 to 10) numerical pain rating scale. In this scale a value of 0 means no pain, and a value of 10 reflects the worst imaginable pain.

    Time frame: 3 months after therapy activation

07

Study locations

1 site
  • Millennium Pain Center
    Bloomington, Illinois 61704, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03954080
Lead sponsor
Millennium Pain Center
Responsible party
Sponsor
First posted
May 17, 2019
Start date
Jun 13, 2019
Primary completion
Mar 23, 2022
Completion
Mar 31, 2022
Last update
Apr 5, 2022

Study contacts

Ricardo Vallejo, MD,PhD
principal investigator · Millennium Pain Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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