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出境医 / 临床实验 / Trialing of ISS in Patients With CRPS

Trialing of ISS in Patients With CRPS

Study Description
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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 : November 15, 2021
Estimated Study Completion Date : December 15, 2021
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

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
Layout table for investigator information
Principal Investigator: Ricardo Vallejo, MD,PhD Millennium Pain Center
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE June 13, 2019
Estimated Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		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 numerical pain rating scale.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trialing of ISS in Patients With CRPS
Official Title  ICMJE Trialing of Intra-spinal Stimulation in Patients With Complex Regional Pain Syndrome or Causalgia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • CRPS I
  • Causalgia
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: ISS
Intervention: Device: Intraspinal-optimal stim therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David L Cedeno, PhD 3092209876 clinical@lumbreraresearch.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954080
Other Study ID Numbers  ICMJE MPC-2019ISS/CRPS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Millennium Pain Center
Study Sponsor  ICMJE Millennium Pain Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ricardo Vallejo, MD,PhD Millennium Pain Center
PRS Account Millennium Pain Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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