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Trialing of ISS in Patients With CRPS

Primary Purpose

CRPS I, Causalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intraspinal-optimal stim therapy

About this trial

This is an interventional treatment trial for CRPS I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Capable of giving written informed consent to participate in this clinical study.
Must be 18 years old or older.
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.
Average pain intensity larger or equal to 6 on the numeric pain rating scale (NPRS).
Appropriate candidate for spinal cord stimulation as determined by the Investigator.
Subjects must be on a stable dose of pain medication regimen for at least 1 month.
Must be able to comply with the requirements of study visits.
Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians.

Exclusion Criteria:

Systemic infection.
Any other active implanted device.
Evidence of serious neurological, psychological or psychiatric disorders.
Previous posterior decompressive laminectomy that precludes appropriate posterior epidural placement of stimulation lead(s).
Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
Human immunodeficiency virus (HIV) infection or a clinically significant infection.
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.
Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
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.
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.
Concurrent participation in another clinical study.
Involvement in an injury or disability claim under current litigation or a pending or approved workers' compensation claim.
Escalating or changing pain condition over the last 30 days that creates difficulty of pain evaluation by the patient.

Sites / Locations

Millennium Pain Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ISS

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03954080

First Posted

May 14, 2019

Last Updated

April 3, 2022

Sponsor

Millennium Pain Center

1. Study Identification

Unique Protocol Identification Number

NCT03954080

Brief Title

Trialing of ISS in Patients With CRPS

Official Title

Trialing of Intra-spinal Stimulation in Patients With Complex Regional Pain Syndrome or Causalgia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

June 13, 2019 (Actual)

Primary Completion Date

March 23, 2022 (Actual)

Study Completion Date

March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Millennium Pain Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CRPS I, Causalgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ISS

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Intraspinal-optimal stim therapy

Intervention Description

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 Measure Information:

Title

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

Description

Time Frame

3 months after therapy activation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Capable of giving written informed consent to participate in this clinical study. Must be 18 years old or older. 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. Average pain intensity larger or equal to 6 on the numeric pain rating scale (NPRS). Appropriate candidate for spinal cord stimulation as determined by the Investigator. Subjects must be on a stable dose of pain medication regimen for at least 1 month. Must be able to comply with the requirements of study visits. Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians. Exclusion Criteria: Systemic infection. Any other active implanted device. Evidence of serious neurological, psychological or psychiatric disorders. Previous posterior decompressive laminectomy that precludes appropriate posterior epidural placement of stimulation lead(s). Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests. Human immunodeficiency virus (HIV) infection or a clinically significant infection. 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. Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension. Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders. 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. 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. Concurrent participation in another clinical study. Involvement in an injury or disability claim under current litigation or a pending or approved workers' compensation claim. Escalating or changing pain condition over the last 30 days that creates difficulty of pain evaluation by the patient.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ricardo Vallejo, MD,PhD

Organizational Affiliation

Millennium Pain Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Millennium Pain Center

City

Bloomington

State/Province

Illinois

ZIP/Postal Code

61704

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Trialing of ISS in Patients With CRPS

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