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NCT Number: NCT07354243

International Neuromodulation Registry

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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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing spinal cord stimulation (SCS) procedures
  • Obtain patient consent based on their local consent models

Exclusion criteria

  • Patient unable to meet study requirements

Treatment and study plan

Neuromodulation therapies

Device

Spinal cord stimulation (SCS) procedures

Primary outcomes

  1. Quality of life

    Time frame: 12 Months

    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.

Other outcomes

  1. Real-world effectiveness

    Time frame: 12 months

    Provide the basis for enhanced assessment of the effectiveness of neuromodulation therapies using real world data.

  2. Develop a model for international collaboration and research.

    Time frame: 12 months

  3. Geographic variations:

    Time frame: 12 Months

    Provide the ability to assess similarities and differences on patients and neuromodulation effectiveness by geographic regions

  4. Create a diversified pool of data for research

    Time frame: 12 Months

  5. Refine the minimum data specification and data standards to support analysis across the pooled data set

    Time frame: 12 Months

  6. Safety and traceability

    Time frame: 12 Months

    Monitor (serious) adverse events, revisions/explants, and device problems; ensure unique device identifier capture to enable post-market surveillance and recall traceability.

Study contacts

Contact information is provided by the study sponsor or research team.

Tia SOFATZIS

CONTACT

[email protected]

415 683 3237

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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