International Neuromodulation Registry

NCT07354243 | Not Yet Recruiting DMC

• 1 other identifier: INR Registry
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Real-world effectiveness

  12 months

• Develop a model for international collaboration and research.

  12 months

• Geographic variations:

  12 Months

Study Arms (1)

Neuromodulation therapies

Device: Neuromodulation therapies

Interventions

Neuromodulation therapies DEVICE

Spinal cord stimulation (SCS) procedures

Neuromodulation therapies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patient unable to meet study requirements

Sponsors & Collaborators

• Poitiers University Hospital: lead

MeSH Terms

Conditions

Neuralgia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Tia SOFATZIS

CONTACT

415 683 3237; tsofatzis@neuromodulation.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 21, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01