Pain, Upper Limb
Conditions
Keywords
upper limb, Spinal Cord Stimulation, Pain
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.
Interventions
DEVICEIntellis 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.
Sponsors
SGX Procura LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A subject must MEET ALL of the following 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
* A subject must NOT MEET ANY of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Implanted Subjects Who Respond to DTM SCS Therapy at 3-months | 3 months | The primary efficacy endpoint is the percentage of implanted subjects who respond to DTM SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in upper limb pain relative to baseline assessment. |
Countries
United States
Participant flow
Recruitment details
1 subject was withdrawn by physician before starting the trial phase.
Pre-assignment details
This is a single-arm observational study.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Treated With DTM SCS Programming Subjects that met inclusion and exclusion criteria are trialed with DTM SCS programming. | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Prior to Trial Phase | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Subjects Treated With DTM SCS Programming | — |
|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 21 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 52 participants | — |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
| Upper Limb Pain | 7.25 units on a scale STANDARD_DEVIATION 1.22 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 58 |
| other Total, other adverse events | 3 / 58 |
| serious Total, serious adverse events | 1 / 58 |
Outcome results
Primary
Percentage of Implanted Subjects Who Respond to DTM SCS Therapy at 3-months
The primary efficacy endpoint is the percentage of implanted subjects who respond to DTM SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in upper limb pain relative to baseline assessment.
Time frame: 3 months
Population: All subjects who receive a permanent SCS system implant. Does not include subjects that failed the trial phase nor subjects that did not receive permanent SCS system.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Treated With DTM SCS Programming | Percentage of Implanted Subjects Who Respond to DTM SCS Therapy at 3-months | 100 percentage of individual responder |