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

NCT ID: NCT03876054

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-13

Study Completion Date

2029-12-31

Brief Summary

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The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.

Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Spinal cord stimulation (SCS)

Subjects using Abbott SCS systems

Spinal cord stimulation (SCS)

Intervention Type DEVICE

Subjects will be implanted with market-released Abbott SCS systems

Dorsal root ganglion stimulation (DRG)

Subjects using Abbott DRG system

Dorsal root ganglion stimulation (DRG)

Intervention Type DEVICE

Subjects will be implanted with market-released Abbott DRG system

Interventions

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Spinal cord stimulation (SCS)

Subjects will be implanted with market-released Abbott SCS systems

Intervention Type DEVICE

Dorsal root ganglion stimulation (DRG)

Subjects will be implanted with market-released Abbott DRG system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject must provide written informed consent prior to any clinical investigation related procedure.
2. 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.
3. Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
4. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

Exclusion Criteria

1. Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
2. 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.
3. Subject has or is scheduled to receive an intrathecal pump.
4. Subject is part of a vulnerable population.
5. Subject has an existing implanted neuromodulation device to address their chronic pain.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Devyani Nanduri

Role: STUDY_DIRECTOR

Abbott Medical Devices Neuromodulation

Locations

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Phoenician Centers for Research & Innovation

Phoenix, Arizona, United States

Site Status TERMINATED

Pain Institute of Southern Arizona

Tucson, Arizona, United States

Site Status TERMINATED

California Orthopedics & Spine

Larkspur, California, United States

Site Status TERMINATED

Restore Orthopedics & Spine Center

Orange, California, United States

Site Status TERMINATED

Foothills Pain Management Clinic

Pomona, California, United States

Site Status TERMINATED

Pacific Research Institute

Santa Rosa, California, United States

Site Status TERMINATED

University of Florida Department of Anesthesia

Gainesville, Florida, United States

Site Status TERMINATED

Rush University Medical Center

Chicago, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

University of Chicago

Chicago, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Goodman Campbell Brain and Spine

Indianapolis, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Nura

Edina, Minnesota, United States

Site Status ACTIVE_NOT_RECRUITING

Twin Cities Pain Clinic

Edina, Minnesota, United States

Site Status TERMINATED

Mayo Clinic

Rochester, Minnesota, United States

Site Status TERMINATED

Saint Louis Pain Consultants

Chesterfield, Missouri, United States

Site Status TERMINATED

Advanced Pain Care

Henderson, Nevada, United States

Site Status TERMINATED

Nevada Advanced Pain Specialists

Reno, Nevada, United States

Site Status TERMINATED

Ainsworth Institute of Pain Management

New York, New York, United States

Site Status TERMINATED

Unity Spine Center

Rochester, New York, United States

Site Status ACTIVE_NOT_RECRUITING

The Spine & Pain Institute of New York

Staten Island, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Premier Pain Solutions

Asheville, North Carolina, United States

Site Status TERMINATED

Adena Bone and Joint Center

Chillicothe, Ohio, United States

Site Status WITHDRAWN

Premier Pain Treatment Institute

Loveland, Ohio, United States

Site Status WITHDRAWN

Pacific Sports & Spine

Eugene, Oregon, United States

Site Status ACTIVE_NOT_RECRUITING

Spinal Diagnostics

Tualatin, Oregon, United States

Site Status TERMINATED

Center for Interventional Pain & Spine

Exton, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Expert Pain

Houston, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Central Texas Pain Institute

Killeen, Texas, United States

Site Status TERMINATED

Integrated Pain Associates

Killeen, Texas, United States

Site Status TERMINATED

Advanced Pain Care

Round Rock, Texas, United States

Site Status TERMINATED

The Spine & Nerve Center of St Francis Hospital

Charleston, West Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Metro Pain Group

Clayton, Victoria, Australia

Site Status TERMINATED

Precision Brain, Spine & Pain Centre

Kew, Victoria, Australia

Site Status TERMINATED

AZ Nikolaas

Sint-Niklaas, Eflndrs, Belgium

Site Status TERMINATED

AZ Delta vzw

Roeselare, West Flanders, Belgium

Site Status TERMINATED

Universitäts Klinikum Tübingen

Tübingen, Bad-wur, Germany

Site Status TERMINATED

Klinikum Ingolstadt GmbH

Ingolstadt, Bavaria, Germany

Site Status ACTIVE_NOT_RECRUITING

Krankenhaus Porz am Rhein

Cologne, Koln, Germany

Site Status RECRUITING

Klinikum Duisburg GmbH

Duisburg, N. RHIN, Germany

Site Status TERMINATED

Universitaetsklinikum Duesseldorf

Düsseldorf, N. RHIN, Germany

Site Status ACTIVE_NOT_RECRUITING

Krankenhaus Neuwerk Maria von den Aposteln

Mönchengladbach, N. RHIN, Germany

Site Status TERMINATED

Kliniken der Stadt Köln-Merheim

Cologne, North Rhine-Westphalia, Germany

Site Status TERMINATED

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Site Status TERMINATED

Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie

Gera, Thuringia, Germany

Site Status TERMINATED

Azienda Ospedaliera Monaldi

Napoli, Campani, Italy

Site Status ACTIVE_NOT_RECRUITING

Fondazione Salvatore Maugeri

Pavia, Lombard, Italy

Site Status ACTIVE_NOT_RECRUITING

Erasmus MC

Rotterdam, S Holln, Netherlands

Site Status ACTIVE_NOT_RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Site Status TERMINATED

Hospital Universitario de Salamanca

Salamanca, Cstleon, Spain

Site Status TERMINATED

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status TERMINATED

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain

Site Status TERMINATED

Hôpital du Valais

Sion, Valais, Switzerland

Site Status ACTIVE_NOT_RECRUITING

Norfolk and Norwich Hospital

Norwich, England, United Kingdom

Site Status TERMINATED

The Walton Centre

Liverpool, North West England, United Kingdom

Site Status TERMINATED

Southmead Hospital

Bristol, Sowest, United Kingdom

Site Status TERMINATED

Seacroft Hospital

Leeds, Yorkshire and the Humber, United Kingdom

Site Status TERMINATED

Countries

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United States Australia Belgium Germany Italy Netherlands Spain Switzerland United Kingdom

Central Contacts

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Bram Blomme

Role: CONTACT

+32 474 74 83 10

Sonar Pradhan

Role: CONTACT

+1 818-282-6456

Other Identifiers

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ABT-CIP-10279

Identifier Type: -

Identifier Source: org_study_id

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