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The design and execution of the International Neuromodulation Society (INS) registry has been developed with the objective of assessing the efficacy and safety of Spinal Cord Stimulation and other neuromodulation therapies using real world data. The analysis of this registry as a data source will inform which therapies and devices are effective across clinics and participating countries.
It is designed to combine data across multiple countries to enable research, benchmarking and device surveillance, and support for implant recalls. By combining longitudinal patient outcomes, device-level surveillance, and cross-center benchmarking, the registry will provide a powerful resource for evidence-based decision-making and international collaboration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromodulation therapies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromodulation therapies | Device | Spinal cord stimulation (SCS) procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | 12 Months |
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| Measure | Description | Time Frame |
|---|---|---|
| Real-world effectiveness | Provide the basis for enhanced assessment of the effectiveness of neuromodulation therapies using real world data. | 12 months |
| Develop a model for international collaboration and research. |
Inclusion Criteria:
Exclusion Criteria:
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In its initial phase, the registry will only include patients undergoing spinal cord stimulation (SCS) procedures at participating centers or through participating national or regional registries. Participating centers will identify eligible patients based on their procedure type and submit data using either the online entry system or bulk upload mechanisms.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tia SOFATZIS | Contact | 415 683 3237 | tsofatzis@neuromodulation.com |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 12 months |
| Geographic variations: | Provide the ability to assess similarities and differences on patients and neuromodulation effectiveness by geographic regions | 12 Months |
| Create a diversified pool of data for research | 12 Months |
| Refine the minimum data specification and data standards to support analysis across the pooled data set | 12 Months |
| Safety and traceability | Monitor (serious) adverse events, revisions/explants, and device problems; ensure unique device identifier capture to enable post-market surveillance and recall traceability. | 12 Months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |