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| Name | Class |
|---|---|
| Saluda Medical Pty Ltd | INDUSTRY |
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The goal of this observational study is to learn about the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy for treatment of painful chemotherapy induced peripheral neuropathy.
The closed-loop SCS (CL-SCS) system stimulates the nerves in the spinal cord, measures their responses and automatically adjust the stimulation level accordingly in real time for each delivered pulse.
Chemotherapy induced peripheral neuropathy (CIPN) is a serious condition that is diagnosed in up to 40% of patients who require chemotherapy. Conventional treatments for painful CIPN include both pharmacological and non-pharmacological interventions, although the underlying evidence is scarce. Spinal cord stimulation is an established treatment for pain associated with painful peripheral neuropathies. Several studies demonstrate pain relief by open-loop spinal cord stimulation (SCS) in patients with painful CIPN, with a positive effect of SCS on pain and quality of life. In the Netherlands, CIPN is an accepted indication for SCS treatment and thus SCS is a regular treatment for patients with painful and refractory CIPN. The closed-loop SCS (CL-SCS) system stimulates the dorsal column in the spinal cord, measures the response through evoked compound action potentials (ECAPs), and automatically adjust the stimulation level accordingly in real time for each delivered pulse.
The current study aims to evaluate the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with CIPN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with painful chemotherapy induced peripheral neuropathy (CIPN) | Subjects diagnosed with painful CIPN and eligible for SCS implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall pain intensity | The primary effectiveness outcome measure is pain intensity measured with the Numeric Rating Scale (NRS; 0 no pain, 10 worst imaginable pain) at 1, 3, 6 and 12 months after SCS implantation. | The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity for the extremities (arms and/or legs) | Pain intensity for the arms and/or legs measured with the Numeric Rating Scale (NRS; 0 no pain, 10 worst imaginable pain). | The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation. |
| 9-Item Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
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Exclusion Criteria:
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Patients with painful chemotherapy induced peripheral neuropathy resistent to conventional medical management. Patients are eligible for SCS implantation and are scheduled to undergo closed-loop SCS implantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esmee Van Leeuwen, MSc | Contact | 088 005 8888 | evanleeuwen@rijnstate.nl | |
| Nick Koning, MD PhD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Recruiting | Arnhem | 6815 AD | Netherlands |
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Assessment of quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) all assessed using the PROMIS-29 questionnaire. PROMIS-29 is scored on a T-score metric with a mean of 50 and a standard deviation of 10 in the U.S. general population, with a higher score representing more symptoms. |
| The difference between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation. |
| CIPN-related symptoms | Assessment of CIPN-related symptoms using the European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20). EORTC QLQ-CIPN20 contains 20 items scored on a 4-point Likert scale for sensory, motor and autonomic symptoms. Scale scores are linearly converted to a 0-100 scale, with higher scores indicating increased symptoms. | The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation. |
| Medication use | Assessment of pain medication use | The change between baseline and the evaluation 1, 3, 6 and 12 months after treatment with closed-loop SCS |
| Patient Global Impression of Change (PGIC) | Assessment of the patient impression of global improvement with treatment using a 7-point rating scale, ranging from 1 to 7. Higher scores indicate a patient perspective of a worsening of the health condition. | The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation. |
| Stimulation coverage and patient stimulation awareness and satisfaction | Assessment of the percentage of stimulation coverage of the painful area, and of stimulation sensation (awareness and quality) during closed-loop spinal cord stimulator (CL-SCS) therapy | Evaluation at 1, 3, 6 and 12 months after SCS implantation |
| SCS stimulation pulse width | The pulse width in milliseconds of the active SCS stimulation program will be collected. | Evaluation at 1, 3, 6 and 12 months after SCS implantation. |
| SCS stimulation frequency | Frequency of the active SCS stimulation program measured in Hertz will be collected | Evaluation at 1, 3, 6 and 12 months after SCS implantation. |
| (Serious) adverse events | Assessment of treatment-related complications | Evaluation at 1, 3, 6 and 12 months after SCS implantation |
| Sint Antonius Ziekenhuis | Recruiting | Nieuwegein | Netherlands |
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| Bravis Hospital | Recruiting | Roosendaal | Netherlands |
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| ETZ | Recruiting | Tilburg | Netherlands |
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| ASZ | Recruiting | Zwijndrecht | Netherlands |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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