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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuropathic Pain
• Intervention / Treatment: Device: Neuromodulation therapies

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Tia SOFATZIS; Phone Number: 415 683 3237; Email: tsofatzis@neuromodulation.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neuromodulation therapies	Device: Neuromodulation therapies; Spinal cord stimulation (SCS) procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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.		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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: INR Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No