Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain

NCT ID: NCT04466111

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2023-03-09

Brief Summary

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach.

Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

Detailed Description

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach.

Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

The expected total duration of this study is approximately 26 months. Enrollment of participants is expected to last 20 months. Participants that have received the permanent implant will be followed up for 12 months after their device has been activated. A participant will likely be committed to the study for about 14 months. This consists of Baseline assessments, up to 10 days of trial stimulation, and 12 months of treatment following implantation and activation of the device. All subjects who plan on remaining implanted through the 6-month visit or who have completed their 6-month visit will be offered to return for an additional 12-month visit. This would increase their commitment to the study to 14 months.

Conditions

Upper Limb; Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Intellis neurostimulator system

The study will use the commercially available IntellisTM neurostimulator and compatible SCS system components from Medtronic using stimulation parameters within the specifications approved for use in the approved indications. The study will stimulate the cervical dorsal columns of the spinal cord.

Intervention Type: DEVICE

Other Intervention Names

Spinal Cord Stimulation (SCS) device system

Eligibility Criteria

Inclusion Criteria

1. Be diagnosed with chronic, intractable pain of the upper limb related to the cervical spine and/or neuropathic arm pain.

2. Be a candidate for SCS system (trial and implant) per labeled indication (upper limb pain due to one of the conditions listed in indications statement)

3. Considering daily activity and rest, has average upper limb pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment

4. Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.

5. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent.

6. Be 18 years of age or older at the time of enrollment

7. Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study

8. Be willing and able to comply with study -related requirements, procedures, and visits, including not increasing pain meds through the three month visit

9. Has adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator

Exclusion Criteria

1. Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator

2. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator

3. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the study manager or designee)

4. Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump.

5. Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator

6. Has significant cervical stenosis, as determined by the Investigator

7. Has facet spondylosis, as determined by the Investigator

8. Has mechanical spine instability, as determined by the Investigator

9. Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat upper limb pain, which is providing significant pain relief

10. Has unresolved major issues of secondary gain (e.g., social, financial, legal, such as worker compensation matters)

11. Be pregnant as determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.

12. Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist

13. Have a current diagnosis of a progressive neurological disease as determined by the Investigator

14. Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus

15. Have a condition that the Investigator determines would significantly increase perioperative risk

16. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) of the cervical spine

17. Have metastatic malignant disease or active local malignant disease

18. Have a life expectancy of less than 1 year

19. Have an active systemic or local infection

20. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SGX Procura LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo Vallejo, MD

Role: STUDY_CHAIR

SGX Medical

Locations

SGX Medical

Bloomington, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DTM-PROC-2020PM3

Identifier Type: -

Identifier Source: org_study_id