Extended Home-use Trial of a Novel Device to Reduce Chronic Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in Neuropathic Pain Symptom Inventory (NPSI)
研究概览
简要总结
Randomized controlled trial to assess the effectiveness and patient perception of the benefit of the Sana Pain Reliever in individuals with chronic neuropathic pain.The study is fully remote with four study visits taking place over teleconferencing and the study devices mailed to the participants to use at home for 8-14 weeks.
详细描述
Chronic neuropathic pain (NP) is an extremely debilitating condition with few treatment options and many of which with multiple side effects. This will be a randomized, sham-controlled trial that will investigate the effectiveness of a novel wearable device called the Sana Pain Reliever (Sana PR) at reducing chronic neuropathic pain. The Sana PR is a device comprised of a Mask to be worn over the eyes with a pair of ear buds to be worn in ears. It displays light and sounds in a predetermined algorithm which runs for 16 minutes at a time. The underlying mechanism of action for the Sana PR is Audio Visual Stimulation (AVS), a form of non-pharmacological intervention that induces a brain wave response called Frequency Following Response (FFR), which has been used for both performance enhancement and symptom management. The device will be used with a compatible tablet application that will collect data from each session that the device is used. This data will be collected through user inputs of responses to several questionnaires. This will be an at-home trial and participants will be loaned the Sana Pain Reliever device and a tablet device to run the application for the duration of the study. The trial will last a total of 14 weeks and will involve four study visits, either in-person at the Abilities Research Center at Mount Sinai Hospital in New York City, or remotely using a video call. The trial includes two baseline sessions on weeks 0 and 2, 8 weeks of the at-home intervention, and post-intervention sessions at the end of weeks 10 and 14. Participants will be instructed to use the device at the end of the day prior to going to sleep as well as whenever they experience greater than typical pain during the day . Data during the at home portion of the trial will be recorded daily via the application. The application will also prompt participants to answer fortnightly weekly questionnaires and send out compliance reminders. Additionally, a series of pain, sleep and quality of life assessments will be completed by participants at both baseline visits, a post-intervention visit and a 4-week follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of neuropathic pain
- •Age of 18 years or older at time of consent
- •Fluent in English
- •Consistent medications for the last 4 weeks prior to the first baseline visit (week 0)
排除标准
- •Diagnosis of photosensitive epilepsy
- •Active ear or eye infection
- •Vision impairments that affect perception of light in one or both eyes
- •Deafness in one or both ears
- •Severe depression (Score higher than 30 points on the Beck's Depression Inventory)
结局指标
主要结局
Change in Neuropathic Pain Symptom Inventory (NPSI)
时间窗: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full scale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain
时间窗: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full subscale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain
时间窗: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP).This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full subscale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain
时间窗: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full subscale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain
时间窗: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full subscale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia
时间窗: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Subscale from 0-100. Full scale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.
Change in Neuropathic Pain Symptom Inventory (NPSI)
时间窗: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full scale from 0-100 with higher score indicating more symptom intensity. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.
次要结局
- Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9)(Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Change in Beck Depression Inventory (BDI)(Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Change in General Anxiety Disorder 7-item Questionnaire (GAD-7)(Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet(Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Change in World Health Organization Quality of Life Bref (WHOQOL-BREF)(Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Change in Patient's Global Impression of Change (PGIC)(Post-assessment (Week 10); Follow up (Week 14))
- Visual Analogue Scale (VAS)-Pain(before and after each time device used up to 14 weeks)
- Visual Analogue Scale (VAS)-Sleep(first 3 days and 14 weeks)
- Change in Beck Depression Inventory (BDI)(Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Change in World Health Organization Quality of Life Bref (WHOQOL-BREF)(Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14))
- Change in Patient's Global Impression of Change (PGIC)(Post-assessment (Week 10); Follow up (Week 14))
研究者
David Putrino
Assistant Professor
Icahn School of Medicine at Mount Sinai