Mechanisms of Stimulation for Pain Alleviation

Обзор

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.

Вмешательства

• Устройство Peripheral Nerve Stimulation
  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
• Процедура Conventional Care Regimen
  CMM-Only participants will receive conventional medical management for the duration of their time in the study.

Первичные конечные точки

• 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. [Срок оценки: Baseline to Month 3]

Вторичные конечные точки (1)

• Trial Response Rate [Срок оценки: Baseline to 15 days]

Критерии участия

Inclusion criteria for study participants

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\*

Критерии исключения

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

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Stanford University — Palo Alto
• The University of Kansas Medical Center — Kansas City

Идентификаторы

NCT: NCT06741579 · 76560 · RM1NS128956-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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