Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:
Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.
There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit.
Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to include an estimated 135 subjects to the point of randomization.
This would allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month endpoint.
The expected total duration of this study is approximately 32 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTM-SCS programming | Active Comparator | This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Test treatments, which may identify the type of treatment to study participants. DTM-SCS programming has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms. |
|
| Conventional SCS programming | Active Comparator | This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Control treatments, which may identify the type of treatment to study participants. Conventional SCS programming is stimulation parameters in the 40-250 Hz frequency range and will be trialed according to standard practice as described in the Intellis labeling/manuals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTM Programming | Device | DTM-SCS programming |
| |
| Conventional SCS programming |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy | The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment. | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ricardo Vallejo, MD | SGX Medical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGX Medical | Bloomington | Illinois | 61704 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
121 subjects met inclusion and exclusion criteria after enrollment were randomized (5 subjects failed screening). 105 subjects successfully randomized subjects completed the trial phase and were included in the Modified Intent to Treat Analysis.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DTM-SCS Programming Group | DTM-SCS program group has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms. |
| FG001 | Conventional SCS Programming Group | Conventional SCS program group has stimulation parameters in the 40-250 Hz frequency range will be trialed according to standard practice as described in the Intellis labeling/manuals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Months |
| |||||||||||||
| 6 Months |
| |||||||||||||
| 9 Months |
| |||||||||||||
| 12 Months |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DTM-SCS Programming Group | DTM-SCS program group has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms. |
| BG001 | Conventional SCS Programming Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy | The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment. | Modified Intent to Treat (mITT): All successfully randomized subjects who complete the Trial Phase. Failed trial subjects and subjects that withdrew due to insufficient pain relief carry forward. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DTM-SCS Programming Group | DTM-SCS program group has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms. All reported adverse events occurred prior to the optional crossover. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal Epidural Hematoma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Clinical Affairs | SGX Medical | 818-527-2710 | clinical@sgxmedical.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2020 | Aug 16, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:
Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.
Not provided
Not provided
Not provided
Not provided
| Device |
Conventional SCS programming |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Conventional SCS program group has stimulation parameters in the 40-250 Hz frequency range will be trialed according to standard practice as described in the Intellis labeling/manuals.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Back Pain VAS | Visual Analog Score (0.0cm to 10.0cm). Higher score represents more pain. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Conventional SCS Programming Group | Conventional SCS program group has stimulation parameters in the 40-250 Hz frequency range will be trialed according to standard practice as described in the Intellis labeling/manuals. |
|
|
| 0 |
| 51 |
| 1 |
| 51 |
| 0 |
| 51 |
| EG001 | Conventional SCS Programming Group | Conventional SCS program group has stimulation parameters in the 40-250 Hz frequency range will be trialed according to standard practice as described in the Intellis labeling/manuals. All reported adverse events occurred prior to the optional crossover. | 0 | 54 | 2 | 54 | 0 | 54 |
| Post Dural Puncture Headache | Nervous system disorders | Systematic Assessment |
|
| Pocket Pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided