NCT03876054 · Abbott Medical Devices
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
(REALITY)
What this study is about
The REALITY study is a forward-looking, post-market, non-randomly assigned, multi-center, single-treatment group$1, where both patients and doctors know the treatment given study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Subject has an existing implanted neuromodulation device to address their chronic pain.
Where
- Phoenix, Arizona
- Tucson, Arizona
- Larkspur, California
- Orange, California
- Pomona, California
- Santa Rosa, California
- Gainesville, Florida
- Chicago, Illinois
- Indianapolis, Indiana
- Edina, Minnesota
- Rochester, Minnesota
- Chesterfield, Missouri
And 15 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations