- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04503109
Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System (nPower™-US)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shilpa Kottalgi, BDS,MAS
- Phone Number: 7608276467
- Email: skottalgi@nalumed.com
Study Locations
-
-
California
-
Larkspur, California, United States, 94939
- CA Ortho and Spine
-
Walnut Creek, California, United States, 94598
- IPM Medical Group, Inc.
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-
District of Columbia
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Washington, District of Columbia, United States, 20006
- International Spine, Pain and Performance Center
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Florida
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Gainesville, Florida, United States, 32607
- The Orthopaedic Institute
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Port Charlotte, Florida, United States, 33948
- Southwest Florida Pain Center
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Georgia
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Atlanta, Georgia, United States, 30326
- Alliance Spine and Pain
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Kansas
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Overland Park, Kansas, United States, 66210
- NeuroScience Research Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73106
- SSM Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Nalu SCS System
All eligible subjects will receive the Nalu Neurostimulation System
|
The Nalu Neurostimulation System is a Spinal Cord Stimulation system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Responders at 3-months
Time Frame: 3 months
|
Number of subjects who have 50% or greater pain reduction from baseline
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAL-01-2020-US
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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