Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Recruiting
Observational Study
Chronic Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
2,000 (estimated)
Sponsor
Abbott Medical Devices · Industry
Who this trial is looking for
This trial is looking for people with chronic pain who are scheduled to get an Abbott neurostimulator. Participants will help researchers gather data on the safety and effectiveness of this device over time.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I can give written consent to take part.
I am scheduled to have an Abbott neurostimulator implanted within 60 days.
I have a pain score of 6 or higher without stimulation.
You may not be able to join if
I am in another clinical study that competes with this one.
I have other medical or psychological conditions that could affect my participation.
I have an intrathecal pump or I'm scheduled to get one.
I belong to a vulnerable population.
I already have an implanted device for my chronic pain.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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. Subj…
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.
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