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临床试验/NCT04795635
NCT04795635进行中(未招募)不适用

A Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain (PTPNP) to Conventional Medical Management (CMM)

NeuraLace Medical, Inc.6 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
61
试验地点
6
主要终点
Comparison of the Proportion of Responders

研究概览

简要总结

Compare Axon Therapy using transcutaneous magnetic stimulation (tMS) against conventional medical management in treating post-traumatic peripheral neuropathic pain (PTPNP).

详细描述

Subjects will be consented, screened, and undergo a 7-day baseline assessment to measure pain scores and assess diary compliance. Subjects who meet inclusion criteria will undergo an in-clinic baseline evaluation, receive randomization assignment, and start their respective treatments.

Those randomized to the CMM plus Axon Therapy group will receive their first Axon Therapy treatment and then have a follow-up phone call after 24 hours to assess if the patient is a candidate for Axon Therapy, that is if the subject is neuropathic or nociceptive. Those that are not candidates for Axon Therapy will be monitored for 30 days for AEs and then they will exit the study as screen failures. Screen failures will not count against enrollment numbers.

All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days), Day 90 (± 14 days), Day 180 (± 14 days) and Day 365 (± 30 days) and if in the CMM plus Axon Therapy group will return to the clinic for Axon Therapy treatments as follows:

  • Month 1: 6 treatments

  • WEEK 1: 3 treatments (consecutive treatments are best)

  • WEEK 2-4: Weekly treatments

  • Month 2: Bi-Weekly treatment

  • Months 3-12: Treatments every 2-4 weeks

  • Additional treatments to treat flare ups; defined as an episode of pain with a VAS >greater or equal to 6 following an increase in daily activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Comparison of the Proportion of Responders

时间窗: 90 days

The primary effectiveness endpoint is a between groups comparison of the proportion of responders, defined as a subject who experiences 50% or greater reduction from baseline in neuropathic pain intensity as measured by in-clinic visual analog score (VAS) for primary area of pain at Day 90 with no increase in baseline pain medications within 4 weeks of the Day 90 visit.

次要结局

  • Depression Anxiety Stress Scales (DASS)(90 days)
  • Patient Global Impression of Change (PGIC)(90 days)
  • Visual Analog Scale (VAS) for Pain(30 and 90 days)
  • Brief Pain (BPI Inventory(90 days)
  • Daily Sleep Interference Scale (DSIS)(30 and 90 days)
  • 5D-5D-3L(90 days)
  • Pain Disability Index (PDI)(90 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

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