Single Center, Single Blind, Randomized, Sham Controlled Pilot Study Using Selective Nerve Stimulation (SNS) Signal for Nerve Modulation With Three Amplitudes (Supra-threshold, Sub-threshold and Sham)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Modulation of Median Nerve Perception or Nerve Physiology
研究概览
简要总结
The purpose of this study is to examine if a new device, the SNS (Selective Nerve Stimulator), is effective in changing the way nerves work as pain killing drugs sometimes do. During this study, the study team will place 2 adhesive patches on the inside of one of the wrists of the non-dominant hand (if the subject is right-handed the electrodes will be placed on the subject's left wrist) of the study subject. These patches will be connected by wires (leads) to a small box with a headphone jack. This is designed to provide gentle electrical stimulation through the skin. This study will look at the amount of change from normal nerve function, the sensory effects (feeling, sensations in the body), and any changes the subject has when performing the 2 hour tests. The safety of the study device will also be evaluated.
详细描述
Single center, single blind, randomized, crossover design, sham controlled pilot study using Selective Nerve Stimulation (SNS) signal for nerve modulation with three amplitudes (supra-threshold,sub-threshold and sham)
The primary objective of this proof of concept study is to:
• Evaluate median nerve modulation with selective nerve stimulation amplitudes (supra-threshold, sub-threshold, and sham) by means of objective quantitative sensory tests (QST) and Sensory Nerve Conduction Threshold Tests (sNCTs) in healthy subjects.
The secondary objectives to be evaluated in this study are to:
- Establish device safety profile
- Evaluate patient reported sensory descriptions and perception during modulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must fulfill all of the following criteria:
- •18 years of age or older
- •Ability to provide written informed consent for participation in this study
- •Ability to understand and willing to comply with all study-related procedures, such as questionnaires, diaries and follow-up visits for the study duration
- •Ability to not use analgesics throughout the duration of the study
排除标准
- •Chronic peripheral pain or diagnosed neuropathy of the median nerve or the cervical spine (C6-C8) as reported by the subject
- •Use of analgesics within 3 days prior to screening / baseline visit and if the subject is unable to refrain from using any analgesics throughout their study participation
- •Metal implants in the forearm
- •Previous nerve damage or bone injury that led to median nerve damage
- •Previous surgery for carpal tunnel release in the non-dominant study hand
- •Skin irritation or active infection at or near the electrode placement sites
- •Allodynia involving the patch application area
- •Known history of allergic reaction to the adhesive, hydrogel or any other component of the electrode or patch
- •Use of an investigational drug or device within 30 days prior to study enrollment.
- •Use of Cardiac pacemaker, implantable cardioverter-defibrillators (ICD's), or other electrostimulation device
- •Currently untreated abuse of drugs and/or alcohol
- •Psychological or medical condition that would make the study participant unadvisable
- •Uncontrolled seizures (averaging > 2 seizures/month)
- •Pregnant, or planning on becoming pregnant or breastfeeding during the study period
- •Co-morbid condition that could limit his/her ability to participate in the study or to comply with the follow-up requirements.
- •Any known inabilities to be evaluated instrumentally by quantitative sensory testing (QST) or sensory nerve conduction threshold tests (sNCTs) for a median nerve neuropathy
研究组 & 干预措施
Supra-threshold
Supra-threshold is defined as the nerve stimulation amplitude at which a subject can tolerate sensory responses (like tingling, tapping in the thumb, index or middle fingers) but will not cause pain or duress to the subject. The intervention (TAMS device), is stimulating through tyco extended wear electrodes that are placed directly on top of non dominant hand healthy median nerve fibers and they feel the paresthesia or tingling sensation.
干预措施: Selective Nerve Stimulation (SNS) stimulator device (Device)
Sub-threshold
Sub-threshold is defined as the nerve stimulation amplitude just below the sensory perception of the subject. The intervention (TAMS device), is stimulating through tyco extended wear electrodes that are placed directly on top of non dominant hand healthy median nerve fibers. Subjects do not feel the paresthesia or tingling sensation despite there being a signal transmitted..
干预措施: Selective Nerve Stimulation (SNS) stimulator device (Device)
Sham Control
All subjects in the sham arm will go through the same process / experimental setup as in each of the active stimulation arms; however there will be no stimulation signal during the sham stimulation (output set and SNS box locked at 0 V). As this is the Sham control, there is no intervention but rather the intevention (TAMS device) setup (Tyco electrodes, wires and stimulator) are sent with the subject as if it were on (and just like Subthreshold arm the subjects cannot feel the stimulation). Audible alerts (to signify that the box is unplugged) will be disabled throughout the duration of the study. This sham arm will be used to assess the placebo effect caused by the stimulation and hence isolate the true effect of stimulation.
干预措施: Selective Nerve Stimulation (SNS) stimulator device (Device)
结局指标
主要结局
Modulation of Median Nerve Perception or Nerve Physiology
时间窗: > 2 weeks
The primary effectiveness endpoints are the modulation of median nerve perception or nerve physiology as measured by: * QST evaluated by method of levels for vibratory perception threshold (VS) in ABeta fibers and for cold sensation threshold (CS) in alpha gamma fibers and warm sensation threshold (WS) in c fibers. * sNCTs Current Perception Threshold (CPT) in ABeta, Alpha gamma and c fibers (CPT2k, CPT250, CPT5 respectively).
次要结局
未报告次要终点