nPower™-US: Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System

Sponsor
Nalu Medical, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04503109
Collaborator
(none)
250
8
1
29.5
31.3
1.1

Study Details

Study Description

Brief Summary

The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety, comfort and compliance 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Nalu Neurostimulation System
N/A

Detailed Description

The study is a prospective, multi-center, open-label, single-arm clinical study with each subject serving as their own control. The study will confirm device efficacy, safety, comfort and compliance with the system.

Subjects who meet the protocol specified eligibility criteria and provide documented informed consent will be considered for study participation. There are three phases in the study: Screening/Baseline Phase, Trial Phase, Permanent Implant Phase. On confirmation of eligibility during the screening/baseline phase, subjects will enter the Trial Phase where they 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, during the trial phase, will continue to the permanent implant phase.

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. Adverse Event data will also be collected to support a safety endpoint.

Multiple outcome domains will be captured throughout the study to confirm system performance and subject response to the device. These include Visual Analogue Scale (VAS) for pain, Numeric Rating Scales for pain, EQ-5D (QoL), the Oswestry Disability Index (ODI), PROMIS Sleep Disturbance SF, Beck's Depression Index (BDI), pain and paresthesia maps, pain and wearability diaries.

At study completion, subjects will return to standard clinical practice.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
Actual Study Start Date :
Jul 16, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Nalu SCS System

All eligible subjects will receive the Nalu Neurostimulation System

Device: Nalu Neurostimulation System
The Nalu Neurostimulation System is a Spinal Cord Stimulation system

Outcome Measures

Primary Outcome Measures

  1. Responders at 3-months [3 months]

    Number of subjects who have 50% or greater pain reduction from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Subject is between 21 and 80 years of age at enrollment.

  2. 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.

  3. Subject's pain is unresponsive to conservative treatment options.

  4. Subject has a VAS Score of at least 6 in the back and/or leg at screening.

Exclusion Criteria:
  1. 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.

  2. Subject has previously failed SCS therapy (either trial system evaluation or permanent implant).

  3. Subject has had an ablative procedure directed at the spinal cord including the dorsal root entry zone (DREZ) or dorsal root ganglion (DRG).

  4. 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).

  5. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CA Ortho and Spine Larkspur California United States 94939
2 IPM Medical Group, Inc. Walnut Creek California United States 94598
3 International Spine, Pain and Performance Center Washington District of Columbia United States 20006
4 The Orthopaedic Institute Gainesville Florida United States 32607
5 Southwest Florida Pain Center Port Charlotte Florida United States 33948
6 Alliance Spine and Pain Atlanta Georgia United States 30326
7 Neuroscience Research Center Overland Park Kansas United States 66210
8 SSM Health Oklahoma City Oklahoma United States 73106

Sponsors and Collaborators

  • Nalu Medical, Inc.

Investigators

  • Study Director: Patrick Martin, Nalu Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nalu Medical, Inc.
ClinicalTrials.gov Identifier:
NCT04503109
Other Study ID Numbers:
  • NAL-01-2020-US
First Posted:
Aug 7, 2020
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Nalu Medical, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022