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
Not provided
Not provided
The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECAP-controlled, closed-loop SCS | Experimental | Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evoke Spinal Cord Stimulation (SCS) System | Device | A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude |
| Measure | Description | Time Frame |
|---|---|---|
| Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System | Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3. | 12-months post-implant |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Visual Analogue Scale (VAS) to rate pain intensity | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant |
| Change in PROMIS-29 | 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Coastal Pain and Spinal Diagnostics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41774424 | Derived | Pope JE, Vu CM, Goree JH, Cornidez EG, Trainor D, Khurram A, Gould I, Karantonis DM. Objective, Same-Day SCS Trials with ECAP-Controlled Closed-Loop Therapy: Depth of Response is Maintained from Trial to 12 months. Pain Ther. 2026 Apr;15(2):569-583. doi: 10.1007/s40122-026-00821-2. Epub 2026 Mar 3. | |
| 38977651 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Single-arm study. Subjects undergo a trial with the device, at which point they are enrolled, prior to receiving a permanent implant. Results are for implanted subjects.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ECAP-controlled, Closed-loop SCS | Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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 | May 27, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant |
| Change in PROMIS-10 Global | 10-item instrument that assesses Physical Health and Mental Health | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant |
| Change in Profile of Mood States (POMS 2-A Short) | 35-item instrument that assesses mood states overall (Total Mood Disturbance) and six mood clusters: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. A scale score is also calculated for Friendliness. | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant |
| Rate of Patient Global Impression of Change (PGIC) | Single item measure of global improvement with treatment | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant |
| Rate of Patient Satisfaction With Therapy | Single item measure of satisfaction with treatment | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant |
| Carlsbad |
| California |
| 92009 |
| United States |
| Pacific Research Institute | Santa Rosa | California | 95403 | United States |
| The Orthopaedic Institute, PA | Gainesville | Florida | 32607 | United States |
| Alliance Spine and Pain Centers | Atlanta | Georgia | 30326 | United States |
| Southern Pain and Spine | Fayetteville | Georgia | 30214 | United States |
| Axis Spine Center | Hayden Lake | Idaho | 83835 | United States |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | United States |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | United States |
| Interventional Spine and Pain Physicians | Maple Grove | Minnesota | 55369 | United States |
| Nevada Advanced Pain Specialists | Reno | Nevada | 89511 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Spinal Diagnostics, PC | Tualatin | Oregon | 97062 | United States |
| Delaware Valley Pain & Spine Institute | Feasterville-Trevose | Pennsylvania | 19053 | United States |
| Center for Interventional Pain and Spine | Lancaster | Pennsylvania | 55419 | United States |
| Sprintz Center for Pain PLLC | Shenandoah | Texas | 77384 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| St. Francis Hospital | Charleston | West Virginia | 25301 | United States |
| Pope JE, Antony A, Petersen EA, Rosen SM, Sayed D, Hunter CW, Goree JH, Vu CM, Bhandal HS, Shumsky PM, Bromberg TA, Smith GL, Lam CM, Kalia H, Lee JM, Khurram A, Gould I, Karantonis DM, Deer TR. Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy. Pain Ther. 2024 Oct;13(5):1173-1185. doi: 10.1007/s40122-024-00631-4. Epub 2024 Jul 9. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ECAP-controlled, Closed-loop SCS | Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System | Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3. | patients who completed the 12-month follow-up visit | Posted | Median | Inter-Quartile Range | ratio | 12-months post-implant |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Pain | Visual Analogue Scale (VAS) to rate pain intensity | Not Posted | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in PROMIS-29 | 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. | Not Posted | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in PROMIS-10 Global | 10-item instrument that assesses Physical Health and Mental Health | Not Posted | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Profile of Mood States (POMS 2-A Short) | 35-item instrument that assesses mood states overall (Total Mood Disturbance) and six mood clusters: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. A scale score is also calculated for Friendliness. | Not Posted | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Rate of Patient Global Impression of Change (PGIC) | Single item measure of global improvement with treatment | Not Posted | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Rate of Patient Satisfaction With Therapy | Single item measure of satisfaction with treatment | Not Posted | end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant | Participants |
AE data were collected from consent through study completion/exit, an average of 1 year.
SAE criteria:
Led to death,
Led to serious deterioration in the health of the subject, and that either resulted in:
Led to fetal distress, fetal death, or congenital anomaly or birth defect.
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 | ECAP-controlled, Closed-loop SCS | Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude | 3 | 300 | 38 | 300 | 59 | 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall or Trip or Slip or Twist | Injury, poisoning and procedural complications | custom coding | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | custom coding | Systematic Assessment |
| |
| Urinary Tract Infection | Renal and urinary disorders | custom coding | Systematic Assessment |
| |
| Cholelithiasis or Gallstones | Hepatobiliary disorders | custom coding | Systematic Assessment |
| |
| Dural Puncture or Tear | Nervous system disorders | custom coding | Systematic Assessment |
| |
| Nerve Root or Spinal Cord Injury | Nervous system disorders | custom coding | Systematic Assessment |
| |
| Overdose | Psychiatric disorders | custom coding | Systematic Assessment |
| |
| Septicemia | Infections and infestations | custom coding | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | custom coding | Systematic Assessment |
| |
| Activities of Daily Living (ADL) Injury | Injury, poisoning and procedural complications | custom coding | Systematic Assessment |
| |
| Allergic Reaction - Medications or Dressings | Immune system disorders | custom coding | Systematic Assessment |
| |
| Arrhythmia and Irregularities | Cardiac disorders | custom coding | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | custom coding | Systematic Assessment |
| |
| Autoimmune, non-specific | Immune system disorders | custom coding | Systematic Assessment |
| |
| Bone Fracture | Musculoskeletal and connective tissue disorders | custom coding | Systematic Assessment |
| |
| Brain Hemorrhage | Nervous system disorders | custom coding | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | custom coding | Systematic Assessment |
| |
| Coronary Artery or Heart Disease | Cardiac disorders | custom coding | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | custom coding | Systematic Assessment |
| |
| Disorientation | Nervous system disorders | custom coding | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | custom coding | Systematic Assessment |
| |
| Hematoma | Immune system disorders | custom coding | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | custom coding | Systematic Assessment |
| |
| Inflammation | Endocrine disorders | custom coding | Systematic Assessment |
| |
| Kidney Problems - Other | Renal and urinary disorders | custom coding | Systematic Assessment |
| |
| MRSA | Infections and infestations | custom coding | Systematic Assessment |
| |
| Myocardial Infarct or Heart Attack | Cardiac disorders | custom coding | Systematic Assessment |
| |
| Non-specific Infection | Immune system disorders | custom coding | Systematic Assessment |
| |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | custom coding | Systematic Assessment |
| |
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | custom coding | Systematic Assessment |
| |
| Spinal Stenosis | Musculoskeletal and connective tissue disorders | custom coding | Systematic Assessment |
| |
| Upper Respiratory Symptoms or Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | custom coding | Systematic Assessment |
| |
| Wound Dehiscence | Immune system disorders | custom coding | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | custom coding | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall or Trip or Slip or Twist | Injury, poisoning and procedural complications | custom coding | Systematic Assessment |
| |
| Upper Respiratory Symptoms or Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | custom coding | Systematic Assessment |
| |
| Activities of Daily Living (ADL) Injury | Injury, poisoning and procedural complications | custom coding | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | custom coding | Systematic Assessment |
|
PI may publish their site's results if:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Leitner | Saluda Medical | 651-208-4223 | angela.leitner@saludamedical.com |
| Dec 9, 2024 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004358 | Drug Therapy |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|