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Trialing of ISS in Patients With CRPS

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ClinicalTrials.gov Identifier: NCT03954080
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Millennium Pain Center

Brief 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.

Condition or disease Intervention/treatment Phase
CRPS I Causalgia Device: Intraspinal-optimal stim therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trialing of Intra-spinal Stimulation in Patients With Complex Regional Pain Syndrome or Causalgia
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ISS Device: Intraspinal-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.




Primary Outcome Measures :
  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 [ Time Frame: 3 months after therapy activation ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

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): NCT03954080


Contacts
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Contact: David L Cedeno, PhD 3092209876 clinical@lumbreraresearch.com

Locations
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United States, Illinois
Millennium Pain Center Recruiting
Bloomington, Illinois, United States, 61704
Contact: David L Cedeno, PhD       clinical@lumbreraresearch.com   
Sponsors and Collaborators
Millennium Pain Center
Investigators
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Principal Investigator: Ricardo Vallejo, MD,PhD Millennium Pain Center

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Responsible Party: Millennium Pain Center
ClinicalTrials.gov Identifier: NCT03954080     History of Changes
Other Study ID Numbers: MPC-2019ISS/CRPS
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Causalgia
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuralgia