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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
What is being tested?
Peripheral Nerve Stimulation and Conventional Care Regimen
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
Show all 25Show fewer
  • 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

  • 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

    Recruiting

Other trials in United States

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.

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 groups in NCT06741579
Study groupRoleWhat they receive
Conventional Medical Management (CMM) ONLYActive comparatorNot described
Receives: Procedure: Conventional Care Regimen
Peripheral Nerve Stimulation + Conventional Medical Management (PNS+CMM)ExperimentalNot 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.

  1. 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)

  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.

  1. First posted19 Dec 2024
  2. Study start26 Sep 2025
  3. Primary completionAug 2028 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT06741579.

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.

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