Dual Stimulation for Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Device Feasibility (functionality of the prototype device)
研究概览
简要总结
The goal of this Spinal Cord Injury (SCI) Open-Label Clinical Trial is to test the safety and feasibility of the intervention. The study aims to answer whether implementing this intervention on inpatients at a specialized rehabilitation hospital is possible. All participants will receive the intervention and be asked to report side effects and tolerability. Additionally, injury markers for safety and signal recordings to detect changes will be assessed pre- and post-intervention.
详细描述
This proposal seeks to apply non-invasive technology for hyperexcitability suppression, decrease inflammation, and promote restorative processes along the neural axis and the brain in patients with complete SCI in a highly innovative treatment paradigm with the potential for large-scale clinical impact.
This project will be the first to examine the proposed treatment approach in subacute inpatients with complete SCI. This will be a pilot open-label study using historical controls from the Spinal Cord Injury Model Data Center. A follow-up period (3- and 6-month post-intervention) will be required to evaluate the progression of these patients. The investigators aim to recruit eight patients based on historical admissions data from our institution.
Specific aims for this project are:
Aim 1: To assess safety and feasibility. Investigators will begin subject enrollment from the SCI inpatient unit at Spaulding Rehabilitation Hospital. The investigators will explore the effects of non-invasive neuromodulation + photobiomodulation among hospitalized American Spinal Cord Injury Association (ASIA) A/B patients (i.e., through analysis of enrollment, treatment tolerability, retention, medication use, and adverse effects).
Aim 2: To explore neurophysiological and clinical markers associated with recovery in SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Men and women aged 18 or older with traumatic SCI (ASIA A-B).
- •The injury has less than six months of evolution.
- •Patients admitted to the Spaulding SCI Rehabilitation Unit at Spaulding Rehabilitation Hospital.
- •Respiratory and hemodynamically stable.
排除标准
- •They have any contraindications for receiving tsDCS, such as skin wounds in the place of application.
- •Any known hypersensitivity to light therapy
- •Any substantial decrease in alertness, language reception, or attention that might interfere with understanding
- •Current use of a ventilator
- •Compromised medical status due to uncontrolled pathologies such as cancer, heart failure, kidney or liver insufficiency, or any other condition which jeopardizes the patient's participation in the study
- •Pregnancy or breastfeeding. People with childbearing capacity who are eligible to participate in the study will be tested for pregnancy by serum human chorionic gonadotropin (hCG) test.
研究组 & 干预措施
Non-invasive dual electrical neuromodulation and photobiomodulation
Trans-spinal direct current stimulation (tsDCS) + peripheral direct current stimulation (pDCS)
Spinal maximum value 4 milliamps (mA) Peripheral maximum value 1 mA Duration per treatment 20 minutes per session Total of 10 sessions
AND
Low-level laser therapy (LLLT) with 635nm red diodes and 405nm violet diode
干预措施: tsDCS+pDCS (Device)
Non-invasive dual electrical neuromodulation and photobiomodulation
Trans-spinal direct current stimulation (tsDCS) + peripheral direct current stimulation (pDCS)
Spinal maximum value 4 milliamps (mA) Peripheral maximum value 1 mA Duration per treatment 20 minutes per session Total of 10 sessions
AND
Low-level laser therapy (LLLT) with 635nm red diodes and 405nm violet diode
干预措施: Low-level laser therapy (Device)
结局指标
主要结局
Device Feasibility (functionality of the prototype device)
时间窗: Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks.
Device feasibility will be evaluated by device operability throughout the intervention period, these measurements will include; skin bioimpedance (Ohms), ramping up and down of electrical current in mA, and voltage stability during the stimulation (mA) period. Skin bioimpedance, ramping, and voltage stability will be combined to report device functionality represented as optimal stimulation or non-optimal.
Intervention safety through adverse events analysis as measured by the Common Terminology Criteria for Adverse Events (CTCAE)
时间窗: Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.
Number of Participants presenting Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
次要结局
- The American Spinal Cord Injury Association test (ASIA)(Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.)
- Visual Analogue Scale (VAS)(Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.)
- Reflex recovery(Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.)
- Spinal Cord Injury - Functional Index (SCI-FI)(Baseline (post consent, before any intervention) at day 0; post-intervention after 2 weeks of 10 consecutive weekdays of treatment (between day 15 and 19); finally at 3- and 6-month follow-up after intervention was finished, with a range of +/- 2 weeks.)
- The modified Ashworth scale (MAS)(Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.)
- The Spinal Cord Injury - Quality of Life (SCI-QOL)(Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.)
- The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale(Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.)
- The Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG)(Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.)
- High-density surface electromyography (HD-sEMG)(Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.)
- Sympathetic skin responses (SSRs)(Baseline at day 0; post-intervention after 10 consecutive days of treatment; finally at 13 weeks and up to 26 weeks follow-up after intervention was finished, with a range of +/- 2 weeks.)
- Skin surveillance(Baseline at day 0; during intervention (10 days) and post-intervention after 10 days)
研究者
Jorge Leon Morales-Quezada, MD, PhD
Associate Research Director, Spaulding Neuromodulation Center
Spaulding Rehabilitation Hospital