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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3NS121563-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Boston Scientific Corporation | INDUSTRY |
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The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.
The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Invariant Pulse(TIP) Stimulation | Active Comparator | The control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters. |
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| Time Variant Pulse (TVP) Stimulation | Experimental | The time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulator | Device | Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient responder rate | The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block. | Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashwin Viswanathan, MD | Contact | 7132138181 | ashwinv@bcm.edu | |
| Luke Jan Gelvoligaya, MA | Contact | 7137987245 | lukejan.gelvoligaya@bcm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ashwin Viswanathan, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Spinal Cord Stimulator | Device | Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation. |
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| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |