Recruiting

REALITYLong-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Neurologic Manifestations+2

+ Pain

+ Signs and Symptoms

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: March 2019
See protocol details

Summary

Principal SponsorAbbott Medical Devices
Study ContactBram BlommeMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 13, 2019

Actual date on which the first participant was enrolled.

This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure patients from approved indications are represented. Individuals who are scheduled to receive an implantable Abbott neurostimulation system are eligible for study consideration. The study will enroll up to 2,000 subjects from up to 100 participating centers. Subject enrollment is expected to be completed within 7 years; subjects will be followed for 5 years. The total duration of the study is expected to be 13 years, including enrollment, data collection from all subjects, and study close out.

Official TitleLong-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
NCT03876054
Principal SponsorAbbott Medical Devices
Study ContactBram BlommeMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsChronic Pain

Criteria

4 inclusion criteria required to participate
Subject must provide written informed consent prior to any clinical investigation related procedure.
Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
5 exclusion criteria prevent from participating
Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
Subject has or is scheduled to receive an intrathecal pump.
Subject is part of a vulnerable population.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 55 locations

Recruiting

Krankenhaus Porz am Rhein

Cologne, GermanyOpen Krankenhaus Porz am Rhein in Google Maps
Suspended

Pain Institute of Southern Arizona

Tucson, United States
Suspended

California Orthopedics & Spine

Larkspur, United States
Suspended

Phoenician Centers for Research & Innovation

Phoenix, United States
Recruiting
55 Study Centers