Peripheral Nerve StimulationPhase 3M-SPANCT06741579
Mechanisms of Stimulation for Pain Alleviation
A Phase 3 study testing Peripheral Nerve Stimulation and Conventional Care Regimen in people with Peripheral Nerve Stimulation and Chronic Neuropathic Pain, run by Stanford University at 2 sites in United States.
Trial summary
This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the upper extremities, lower back, pelvis, and lower extremities, randomized to conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Stimulation, Chronic Neuropathic Pain, Chronic Neuropathic Pain (Below the Shoulders)
- What is being tested?
- Peripheral Nerve Stimulation and Conventional Care Regimen
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2025to 1 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 or older with clinically diagnosed unilateral CNP in the upper extremities, lower back, pelvis, or lower extremities, defined (per IASP classification) as persistent or recurrent neuropathic pain caused by a peripheral nerve lesion, history of a plausible nerve trauma, pain onset in temporal relation to the trauma, and pain distribution within the innervation territory of a peripheral nerve (or nerves).14 Negative and positive sensory symptoms or signs must be compatible with the innervation territory of the affected nerve. Can be post-traumatic, post-surgical, nerve compression, nerve ischemia, peripheral nerve injury, painful scar, nerve entrapment, mononeuropathy with or without loss of motor function
- Patients enrolled in this study must already have been referred for or have an existing order for PNS therapy (either Nalu or SPR SPRINT), prior to consent and enrollment in this study, as part of their routine medical care. Patients cannot receive a referral for PNS device as part of the study procedures.
- Positive response (at least 50% pain relief) to diagnostic nerve block(s) at the suspected site(s) of CNP.
- Chronic (at least 6 months duration), intractable peripheral neuropathic pain; any nociceptive pain must be less prominent than the neuropathic pian.
- Fluent in English writing, reading, and speaking
- Ability and willingness to complete online assessments
- Willingness to refrain from physical activity for at least 7 days post-lead placement.
- Willingness to refrain from physical activity or exercise causing muscle and/or joint soreness for 48 hours prior to QST, illicit drugs (marijuana) for 12 hours, as-needed (PRN) pain medications (e.g., NSAIDs, acetaminophen, opioids) for 12 hours prior to QST, and alcohol and nicotine on the day of QST prior to testing
Who cannot join
- Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
- Active cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome
- Painful polyneuropathy (e.g., metabolic, autoimmune, familial, infectious disease, environmental toxins, treatment with neurotoxic drug)
- Chronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis)
- Peripheral vascular disease
- Diabetic neuropathy
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- Another pain diagnosis affecting the CNP site that could interfere with study procedures, accurate reporting and/or could confound evaluation of study endpoints (e.g., post-herpetic neuralgia)
- Other active implantable devices (e.g., implantable cardioverter defibrillator, spinal cord stimulator, dorsal root ganglion stimulator, sacral nerve stimulator, deep brain stimulator, intrathecal pump)
- Pregnancy, breastfeeding, or planning to conceive
- Systemic infection or local infection at the anticipated PNS implant site
- Immunocompromised state
- Coagulation disorder, bleeding diathesis, platelet dysfunction, active anticoagulation
- Interventional procedure and/or surgery to treat CNP in the last 30 days (subjects should be enrolled 30 days after last procedure, for prior ablative treatment must be enrolled at least 3 months after last procedure)
- Untreated substance use disorder
- Participating in another clinical trial with an active treatment arm
- Numbness or loss of sensation at the bilateral thumbnails, peripheral neuropathy in the hands, circulatory or sensory problem in the hands
- Participants with a history of Raynaud's Syndrome
- Participants with SBP ≥150 and/or DBP ≥100
- QST Inclusion/Exclusion Criteria. Participants can still be enrolled if they have the QST-only exclusionary criteria have the QST-only exclusionary criteria, but QST will be modified based on responses
- Additional Exclusion Criteria for Subjects receiving PET/MRI and PET/CT imaging at Stanford:
- Prior radiation exposure of >2 rem total within the last 12 months
- Standard contraindications that would preclude MRI including pacemakers or other electronic implants, metal foreign objects or fragments in the eye or body, and aneurysm clips.
- Claustrophobia
- Inability to understand and communicate with the investigators to complete the study related questionnaires
- Females with positive pregnancy test.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Andrea Chadwick, M.D., MSc, FASA, 913-588-3479, achadwick@kumc.edu
- Recruiting
Stanford University
Palo Alto, California, 94304
Jennifer Hah, 6507243193, jhah@stanford.edu
Jennifer Hah, MD, MS
About this study
This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the upper extremities, lower back, pelvis, and lower extremities, randomized to conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). Our goal is to compare treatment outcomes and trial response rate across the control and interventional device groups.
- Conditions
- Peripheral Nerve Stimulation, Chronic Neuropathic Pain, Chronic Neuropathic Pain (Below the Shoulders)
- Being tested
- Peripheral Nerve Stimulation, Conventional Care Regimen
- Keywords
- SPRINT PNS, NALU PNS, Peripheral Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve StimulationDevice
This trial studies 2 FDA approved peripheral nerve stimulation devices that may reduce pain by sending electrical pulses to the nerve. The SPR SPRINT PNS System, a matchbox-sized, battery-powered wearable stimulator that uses a Mircrolead to deliver stimulation for pain relief. There is a small wireless hand-held remote that is used to activate/ adjust intensity of stimulation. Stimulation delivered by this device may interrupt pain signals and increase non-pain signals. The SPR SPRINT device is used for 60 days before the percutaneous Microlead(s) are removed. The Nalu PNS System, a dime-sized micro-implantable pulse generator (IPG) leveraging advanced microelectronics. The micro-IPG is powered by an externally worn therapy disc via radiofrequency worn over the IPG site with an adhesive clip applied to the skin or a relief belt. The device is remote-controlled by patients via an app.
Conventional Care RegimenProcedure or surgery
CMM-Only participants will receive conventional medical management for the duration of their time in the study.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Medical Management (CMM) ONLY | Active comparator | Not described Receives: Procedure: Conventional Care Regimen |
| Peripheral Nerve Stimulation + Conventional Medical Management (PNS+CMM) | Experimental | Not described Receives: Device: Peripheral Nerve Stimulation; Procedure: Conventional Care Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response: defined as 50% relief of average pain intensity at the area of the upper extremities, lower back, pelvic, or lower extremity CNP. We will compare the means of a 3-day diary of numeric rating scale of pain (NRS) intensity scores.
We will compare the mean of a three-day diary of numeric rating scale of pain (NRS) intensity scores (0-10 scale) at baseline to the mean of a three-day diary of NRS scores at 3 months comparing all participants randomized to CMM vs. PNS+CMM.
Measured: Baseline to Month 3
Secondary outcomes (1)
Trial Response Rate
Defined as 50% relief of average pain intensity comparing the mean of a three-day diary of NRS scores at baseline to the mean of a three-day diary of NRS scores at 15 days comparing participants randomized to CMM vs. PNS+CMM. This outcome will be assessed either 15 days after baseline assessments among participants randomized to CMM, 15 days after Nalu PNS trial lead placement, or 15 days after SPR Sprint PNS microlead placement.
Measured: Baseline to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start26 Sep 2025
- Primary completionAug 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve StimulationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), University of Kansas Medical Center
- Responsible party
- Principal investigator, Jennifer Hah, Stanford University
- Investigators
- Jennifer Hah, MD, MS., Principal investigator, Stanford UniversityAndrea Chadwick, M.D., MSc, FASA, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741579
- Sponsor's protocol ID
- 76560
- Other IDs
- RM1NS128956-01A1
- Acronym
- M-SPA
- Status last verified
- Sep 2025
- First submitted
- 25 Nov 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Stimulation for Pain Alleviation
- ClinicalTrials.gov ID
- NCT06741579
- Acronym / sponsor ID
- M-SPA / 76560
- Conditions
- Peripheral Nerve Stimulation, Chronic Neuropathic Pain, Chronic Neuropathic Pain (Below the Shoulders)
- Keywords
- SPRINT PNS, NALU PNS, Peripheral Nerve Stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), University of Kansas Medical Center
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the upper extremities, lower back, pelvis, and lower extremities, randomized to conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). Our goal is to compare treatment outcomes and trial response rate across the control and interventional device groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Medical Management (CMM) ONLY | Active comparator | Procedure: Conventional Care Regimen |
| Peripheral Nerve Stimulation + Conventional Medical Management (PNS+CMM) | Experimental | Device: Peripheral Nerve Stimulation, Procedure: Conventional Care Regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 or older with clinically diagnosed unilateral CNP in the upper extremities, lower back, pelvis, or lower extremities, defined (per IASP classification) as persistent or recurrent neuropathic pain caused by a peripheral nerve lesion, history of a plausible nerve trauma, pain onset in temporal relation to the trauma, and pain distribution within the innervation territory of a peripheral nerve (or nerves).14 Negative and positive sensory symptoms or signs must be compatible with the innervation territory of the affected nerve. Can be post-traumatic, post-surgical, nerve compression, nerve ischemia, peripheral nerve injury, painful scar, nerve entrapment, mononeuropathy with or without loss of motor function
- Patients enrolled in this study must already have been referred for or have an existing order for PNS therapy (either Nalu or SPR SPRINT), prior to consent and enrollment in this study, as part of their routine medical care. Patients cannot receive a referral for PNS device as part of the study procedures.
- Positive response (at least 50% pain relief) to diagnostic nerve block(s) at the suspected site(s) of CNP.
- Chronic (at least 6 months duration), intractable peripheral neuropathic pain; any nociceptive pain must be less prominent than the neuropathic pian.
- Fluent in English writing, reading, and speaking
Key exclusion criteria (25 listed)
- Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
- Active cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome
- Painful polyneuropathy (e.g., metabolic, autoimmune, familial, infectious disease, environmental toxins, treatment with neurotoxic drug)
- Chronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis)
- Peripheral vascular disease
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 |
|---|---|---|
| Peripheral Nerve StimulationThis trial studies 2 FDA approved peripheral nerve stimulation devices that may reduce pain by sending electrical pulses to the nerve. The SPR SPRINT PNS System, a matchbox-sized, battery-powered wearable stimulator that uses a Mircrolead to deliver stimulation for pain relief. There is a small wireless hand-held remote that is used to activate/ adjust intensity of stimulation. Stimulation delivered by this device may interrupt pain signals and increase non-pain signals. The SPR SPRINT device is used for 60 days before the percutaneous Microlead(s) are removed. The Nalu PNS System, a dime-sized micro-implantable pulse generator (IPG) leveraging advanced microelectronics. The micro-IPG is powered by an externally worn therapy disc via radiofrequency worn over the IPG site with an adhesive clip applied to the skin or a relief belt. The device is remote-controlled by patients via an app. | Device | Peripheral Nerve Stimulation + Conventional Medical Management (PNS+CMM) |
| Conventional Care RegimenCMM-Only participants will receive conventional medical management for the duration of their time in the study. | Procedure or surgery | Conventional Medical Management (CMM) ONLY, Peripheral Nerve Stimulation + Conventional Medical Management (PNS+CMM) |
Primary outcome
Treatment Response: defined as 50% relief of average pain intensity at the area of the upper extremities, lower back, pelvic, or lower extremity CNP. We will compare the means of a 3-day diary of numeric rating scale of pain (NRS) intensity scores.
Time frame: Baseline to Month 3
We will compare the mean of a three-day diary of numeric rating scale of pain (NRS) intensity scores (0-10 scale) at baseline to the mean of a three-day diary of NRS scores at 3 months comparing all participants randomized to CMM vs. PNS+CMM.
1 secondary outcome
Trial Response Rate
Time frame: Baseline to 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- SPR Therapeutics - SPRINT PNS System OverviewLink provided by the sponsor.
- NALU Neurostimulation - NALU PNS System OverviewLink provided by the sponsor.
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Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study
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Enrolling by invitation
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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.
Jennifer Hah, MD, MS. principal investigator
Stanford University
Andrea Chadwick, M.D., MSc, FASA principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peripheral Nerve Stimulation and Conventional Care Regimen in people with Peripheral Nerve Stimulation and Chronic Neuropathic Pain, run by Stanford University at 2 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 8 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Response: defined as 50% relief of average pain intensity at the area of the upper extremities, lower back, pelvic, or lower extremity CNP. We will compare the means of a 3-day diary of numeric rating scale of pain (NRS) intensity scores. (time frame: Baseline to Month 3). 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 23 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.