Pain, ChronicnPower™-USNCT04503109
Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
A study testing Nalu Neurostimulation System in people with Pain, Chronic and Pain, Intractable, run by Nalu Medical, Inc. at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Pain, Chronic, Pain, Intractable, Pain, Back
- What is being tested?
- Nalu Neurostimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Jul 2020to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between 21 and 80 years of age at enrollment.
- Subject has chronic (defined as at least 6 months duration), intractable neuropathic pain of legs and/or back; any nociceptive pain must be less prominent than the neuropathic pain.
- Subject's pain is unresponsive to conservative treatment options.
- Subject has a VAS Score of at least 6 in the back and/or leg at screening.
Who cannot join
- Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
- Subject has previously failed SCS therapy (either trial system evaluation or permanent implant).
- Subject has had an ablative procedure directed at the spinal cord including the dorsal root entry zone (DREZ) or dorsal root ganglion (DRG).
- Subject has pain in another anatomic region besides the leg(s) and back that would interfere with their ability to accurately report pain (e.g. hip joint pain).
- Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Alliance Spine and Pain
Atlanta, Georgia, 30326
The Orthopaedic Institute
Gainesville, Florida, 32607
CA Ortho and Spine
Larkspur, California, 94939
SSM Health
Oklahoma City, Oklahoma, 73106
Neuroscience Research Center
Overland Park, Kansas, 66210
Southwest Florida Pain Center
Port Charlotte, Florida, 33948
IPM Medical Group, Inc.
Walnut Creek, California, 94598
International Spine, Pain and Performance Center
Washington D.C., District of Columbia, 20006
About this study
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.
Read the detailed description
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.
- Conditions
- Pain, Chronic, Pain, Intractable, Pain, Back
- Being tested
- Nalu Neurostimulation System
- Keywords
- Spinal Cord Stimulation, Chronic Leg and Back Pain, Failed Back Surgery Syndrome (FBSS)
- Medical subject headings
- Chronic Pain, Pain, Intractable, Back Pain, Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalu Neurostimulation SystemDevice
The Nalu Neurostimulation System is a Spinal Cord Stimulation system
| Study group | Role | What they receive |
|---|---|---|
| Nalu SCS System | Other | All eligible subjects will receive the Nalu Neurostimulation System Receives: Device: Nalu Neurostimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate
Subjects with 50% or greater pain reduction from baseline on the VAS pain scale for leg and/or back
Measured: 3 months post device activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start16 Jul 2020
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nalu Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shilpa Kottalgi, Study director, Nalu Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503109
- Sponsor's protocol ID
- NAL-01-2020-US
- Acronym
- nPower™-US
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2020
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
- ClinicalTrials.gov ID
- NCT04503109
- Acronym / sponsor ID
- nPower™-US / NAL-01-2020-US
- Conditions
- Pain, Chronic, Pain, Intractable, Pain, Back
- Keywords
- Spinal Cord Stimulation, Chronic Leg and Back Pain, Failed Back Surgery Syndrome (FBSS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Nalu Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nalu SCS System | Other | Device: Nalu Neurostimulation SystemAll eligible subjects will receive the Nalu Neurostimulation System |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is between 21 and 80 years of age at enrollment.
- Subject has chronic (defined as at least 6 months duration), intractable neuropathic pain of legs and/or back; any nociceptive pain must be less prominent than the neuropathic pain.
- Subject's pain is unresponsive to conservative treatment options.
- Subject has a VAS Score of at least 6 in the back and/or leg at screening.
Key exclusion criteria (5 listed)
- Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
- Subject has previously failed SCS therapy (either trial system evaluation or permanent implant).
- Subject has had an ablative procedure directed at the spinal cord including the dorsal root entry zone (DREZ) or dorsal root ganglion (DRG).
- Subject has pain in another anatomic region besides the leg(s) and back that would interfere with their ability to accurately report pain (e.g. hip joint pain).
- Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalu Neurostimulation SystemThe Nalu Neurostimulation System is a Spinal Cord Stimulation system | Device | Nalu SCS System |
Primary outcome
Responder Rate
Time frame: 3 months post device activation
Subjects with 50% or greater pain reduction from baseline on the VAS pain scale for leg and/or back
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shilpa Kottalgi study director
Nalu Medical
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nalu Neurostimulation System in people with Pain, Chronic and Pain, Intractable, run by Nalu Medical, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate (time frame: 3 months post device activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.