Noninvasive Spinal Cord Neuromodulation to Improve Lower Urinary Tract Function After Spinal Cord Injury in Ukrainian War Veterans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Neurogenic Bladder Symptom Score (NBSS)
研究概览
简要总结
The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of lower urinary tract (LUT), bowel, sexual, and cardiovascular function, as well as spasticity in individuals with subacute SCI (time since injury 3-6 months) and the impact on quality of life. The study will be conducted at two sites; site 1 in Canada and site 2 in the Ukraine. Up to 60 subjects will be enrolled; 10 adults at the ICORD, University of British Columbia (UBC), Vancouver, Canada site and 50 adults at the Rivne Regional War Veterans Hospital, Rivne, Ukraine. Eligible participants will be randomized (1:1 ratio) either to Group 1 (G1) or Group 2 (G2). G1 will receive therapeutic TSCS for 8 weeks (3 times per week; 1 hour per session) in conjunction with conventional rehabilitation (3-4 hours per day; 5 days per week). G2 will receive 8 weeks of sham stimulation in conjunction with conventional rehabilitation. After 8 weeks, G2 will cross over and receive therapeutic TSCS for 8 weeks, whereas G1 will continue to receive TSCS therapy for another 8 weeks, for a total of 16 weeks. Eligible participants enrolled into the study will attend fifty eight (58) visits for assessments, therapy, and follow-up. The expected duration of study participation for each participant will be 33 weeks.
详细描述
PURPOSE:
The purpose of this clinical study is to investigate the safety and effectiveness of non-surgical transcutaneous spinal cord stimulation (TSCS) in helping with recovery of bladder function in individuals with SCI. Assessments: The immediate effects of TSCS (i.e., effects with stimulation on), long-term effects of TSCS, and the persisting effects of TSCS (i.e., any changes in function that are still present with stimulation off, after several weeks of using the stimulation regularly -pre versus post study comparison). This is a Phase II study. A Phase II study is undertaken after preliminary safety testing for a treatment.
Investigational Study Device:
The SCONE™ (Spinal COrd NEuromodulation) class II investigational device is a non-invasive central nervous system (CNS) stimulator (electrical continence device) designed to provide TSCS for the improvement of symptoms of bladder dysfunction associated with centrally-mediated NLUTD.
The SCONE™ device's primary mechanism of action is electrical stimulation delivered to the spinal cord through the skin. The device consists of an electrode connected by an electrical cable to a battery-powered pulse source and uses advanced waveforms to deliver electrical stimulation directly to the spinal cord neural networks associated with pelvic floor function with the aim to activate and retrain the neural circuits responsible for urinary bladder control.
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
- Single (Participant)
盲法说明
single-blinded, sham-controlled clinical trial
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A participant must meet all of the following criteria in order to be eligible to participate:
- •Age between 19 and 65 years at the time of consent
- •Subacute SCI (time since injury 3-6months)
- •ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10
- •Documented impaired LUT function
- •Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- •i. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.
- •ii. Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
- •Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
- •Must provide informed consent.
- •Agrees to comply with all planned visits and assessments, adhere with established bowel and LUT routines and refrain from initiation of new medications for bowel and LUT management without notifying the Principal Investigator of this study.
排除标准
- •A participant who meets any of the following criteria will be ineligible to participate:
- •Clinically significant depression with thoughts of suicidal ideation (PHQ-9 total score above 20) or debilitating PTSD (PCL-5 total score above) or as judged by the investigator
- •History of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
- •Exhibits signs of lower motor neuron injury (i.e., concomitant conus medullaris/cauda equina injury).
- •History of intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months of baseline visit.
- •Concurrent use of any medication or treatment that in the opinion of the investigator interferes with study outcomes.
- •Presence of cognitive impairments, social/psychological problems, or other comorbid conditions that, in the opinion of the Investigator, will preclude them from participation and completion of the study
- •Presence of severe acute medical issues that interfere with testing (e.g., stage 3/4 pressure ulcers, uncontrolled diabetes).
- •Contraindications for TSCS, such as:
- •Implanted Cardiac pacemaker 8.2 Implanted metal in the trunk or spinal cord 8.3 Intrathecal delivery system (e.g., baclofen pump) 8.4 Implanted central or peripheral neuromodulator
- •Medical condition that may put the participant at risk as determined by the investigator.
- •Participation in or plans to participate in another research study that may interfere with the study endpoints.
结局指标
主要结局
Change in Neurogenic Bladder Symptom Score (NBSS)
时间窗: At baseline; At 8 weeks after treatment vs. sham; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation
Change in Neurogenic Bladder Symptom Score (NBSS) by 10-points at 8 weeks of therapy. The NBSS is a comprehensive and validated survey that quantifies symptoms of neurogenic lower urinary tract dysfunction (NLUTD). A minimum change of 5 points on the NBSS demonstrates clinically meaningful improvement for this patient population as established in the literature.
次要结局
- Mean change in voiding efficacy by at least 50%(At baseline; At 8 weeks after treatment vs. sham; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation)
- Mean change in time needed for bowel movement (TNFBM) by at least 50%(At baseline; At 8 weeks after treatment vs. sham; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation)
研究者
Andrei Krassioukov
MD, Professor in Physical Medicine and Rehabilitation
University of British Columbia