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
Not provided
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Twenty-four patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD Study Electrode | Device | The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale | Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| McGill Pain Questionnaire (MPQ) | Patients select words that describe their pain. There are a total of 15 words. A higher score (more words selected) indicates worse outcome with a range from 0-15. | 3 month |
| Oswestry Disability Index (ODI) |
| Measure | Description | Time Frame |
|---|---|---|
| PainDetect | Ensures patient's pain is neuropathic in nature | Baseline |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical College | Albany | New York | 12208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38376181 | Derived | Berwal D, Quintero A, Telkes I, DiMarzio M, Harland T, Paniccioli S, Dalfino J, Iyassu Y, McLaughlin BL, Pilitsis JG. Improved Selectivity in Eliciting Evoked Electromyography Responses With High-Resolution Spinal Cord Stimulation. Neurosurgery. 2024 Aug 1;95(2):322-329. doi: 10.1227/neu.0000000000002878. Epub 2024 Feb 20. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 31, 2025 | |
| Reset | Apr 16, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 31, 2025 | Apr 16, 2025 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| D055111 | Failed Back Surgery Syndrome |
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Statistics will be performed comparing the HR-SCS to commercial SCS devices. Additionally, we will correlate patient reported outcomes and spinal measurements to IONM outcomes to determine overall device capabilities.
Not provided
Not provided
Not provided
Not provided
|
This is a multiple choice style scale where patients are presented with an activity and asked to select a description which best matches their ability to perform that activity. Multiple choice options are then scored on a scale from 0-5; where 0 is no issues performing the activity and 5 is cannot perform activity. A higher score indicates worse outcome. The range in scores is from 0-100.
| 3 months |
| Pain Catastrophizing Scale (PCS) | Patients are presented with a series of statements and they are asked to rate on a scale from 0-4, how often these statements apply to them when they are in pain. 0= never and 4= always. A higher score indicates worse outcome. Scores range from 0-52. | 3 months |
| Beck Depression Index (BDI) | This is a multiple choice style scale where patients are asked to select a statement related to a feeling of sadness or a component of depression. Multiple choice options are then scored on a scale from 0-3; where 0 is they do not feel that way and 3 is they do feel that way. A higher score indicates worse outcome. Scores range from 0-63 | 3 months |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001416 | Back Pain |
| D001342 | Autonomic Nervous System Diseases |