An interventional study of Nalu Neurostimulation System in Pain, Chronic, Pain, Intractable and Pain, Back, sponsored by Nalu Medical, Inc.. Completed at 8 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Nalu Medical, Inc. (part of Boston Scientific Corporation) · Not applicable, Interventional, and Treatment
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety with the Nalu Neurostimulation System in adult subjects with chronic pain in the legs and back. Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation System.
The study is a prospective, multi-center, open-label, single-arm clinical study.
Subjects who meet the protocol specified eligibility criteria and provide documented informed consent will be considered for study participation. On confirmation of eligibility, subjects will undergo a trial with the Nalu Neurostimulation System. Trials will be done per standard clinical practice and per system IFU. Subjects receiving at least 50% reduction in their back pain will receive a permanent implant.
Eligible subjects will receive the Nalu Neurostimulation System per standard surgical and medical practices and will be programmed for stimulation with one or more therapies to optimize pain reduction. All subjects receiving a permanent implant will be followed for 3-months post device activation. They will visit the clinic at 1 month and 3-months follow-up and programming, as required. Visual Analogue Scale (VAS) will be used to capture outcomes for pain, both leg and back. At study completion, subjects will return to standard clinical practice. Adverse Event data will also be collected to support a safety endpoint.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 110 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Nalu Medical, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
First submitted before Nalu Medical, Inc. became part of Boston Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All eligible subjects will receive the Nalu Neurostimulation System
Device: Nalu Neurostimulation System
The Nalu Neurostimulation System is a Spinal Cord Stimulation system
Responder Rate
Subjects with 50% or greater pain reduction from baseline on the VAS pain scale for leg and/or back
Time frame: 3 months post device activation
| Milestone | Nalu SCS System |
|---|---|
| Started | 110 |
| Completed | 35 |
| Not completed | 75 |
| Withdrew: Did not meet i/e criteria | 41 |
| Withdrew: Withdrawal by subject | 16 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Protocol violation | 8 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawn due to drug abuse | 1 |
| Withdrew: Trial non-responders | 6 |
Subjects with 50% or greater pain reduction from baseline on the VAS pain scale for leg and/or back
| Participants | Nalu SCS System |
|---|---|
| Responder Rate | 30 |
Collected over From the time a subject signs the study informed consent through study completion or withdrawal (up to 9 months). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nalu SCS System | 1/110 (0.9%) | 2/110 (1.8%) | 21/110 (19.1%) |
| Event | Nalu SCS System |
|---|---|
| COPDRespiratory, thoracic and mediastinal disorders | 1/110 |
| DrowzinessGeneral disorders | 1/110 |
| Event | Nalu SCS System |
|---|---|
| Skin irritation including redness, itching and bumpinessMusculoskeletal and connective tissue disorders | 7/110 |
| migration of lead and/or implantable pulse generatorProduct Issues | 5/110 |
| Worsening Pain in back/SI Joint/shoulderMusculoskeletal and connective tissue disorders | 5/110 |
| New pain in legs/thighs/backMusculoskeletal and connective tissue disorders | 4/110 |
Subjects who were implanted with a permanent SCS device and completed the 3-month timepoint per protocol
| Age, Continuous(years) | Nalu SCS System |
|---|---|
| Mean | 55.9 ± 11.8 |
| Sex: Female, Male(Participants) | Nalu SCS System |
|---|---|
| Female | 19 |
| Male | 16 |
| Race/Ethnicity, Customized(Participants) | Nalu SCS System |
|---|---|
| Race — White | 28 |
| Race — Black/African American | 6 |
| Race — Not Specified | 1 |
| Region of Enrollment(participants) | Nalu SCS System |
|---|---|
| United States | 35 |
| Body Mass Index(kg/m^2) | Nalu SCS System |
|---|---|
| Mean | 31.38 ± 5.08 |
| Years since diagnosis(years) | Nalu SCS System |
|---|---|
| Mean | 10.46 ± 9.46 |
| Visual Analogue Scale (VAS)- Leg(mms) | Nalu SCS System |
|---|---|
| Mean | 72.1 ± 17.9 |
| Visual Analogue Scale (VAS)- Back(mms) | Nalu SCS System |
|---|---|
| Mean | 78 ± 15.4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2020 to primary completion in Sep 2022, 25 months.
Results were first posted in Nov 2026, 4 years 1 month after primary completion.
Of 83 industry-sponsored interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 25 months is above that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.