Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in resting anorectal pressure determined via anorectal manometry
研究概览
简要总结
Recent findings have demonstrated that electrical stimulation to the spinal cord (i.e. implanted electrodes) can significantly recover bladder, bowel, and sexual function after injury. While promising, a major drawback is that individuals must undergo a highly invasive and expensive surgical procedure to implant the stimulator on top of the spinal cord. Moreover, the inability to re-position the implanted stimulator considerably limits the flexibility of this procedure.
In this project, the investigators propose a comprehensive clinical study examining the effects of TCSCS in promoting recovery of these crucial functions in individuals with spinal cord injury (SCI). This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.
详细描述
For decades, clinicians and scientists have focused on finding a cure for paralysis. However, research has shown that individuals with SCI more highly prioritize bladder, bowel and sexual functioning over the ability to walk again. There is still a major lack of research towards improving these critical components of autonomic recovery following SCI. This clinical study examines the EFFECTS OF TRANSCUTANEOUS SPINAL CORD STIMULATION (TCSCS) in promoting recovery of bladder, bowel and sexual functions in individuals with SCI. This NON-INVASIVE THERAPEUTIC METHOD utilizes electrodes applied over the skin, and is based on ground-breaking work (from the investigator's group and others), showing that spinal cord stimulation can promote motor and autonomic recovery in individuals with chronic SCI. This study is a collaborative effort between clinicians and scientists with expertise in: SCI care, rehabilitation, bladder, bowel, cardiovascular and sexual functioning.
Safety will be routinely monitored. Six weeks after completion of stimulation experiments, bladder, bowel and sexual function will be reassessed to examine the longevity of TCSCS-induced effects. TCSCS COULD OFFER A SIMPLE, COST-EFFECTIVE SOLUTION TO TREAT AUTONOMIC DYSFUNCTIONS (i.e. urine and faecal incontinence, erectile difficulties etc.) that would undoubtedly significantly improve overall health related quality of life for individuals with SCI.
Recent findings have demonstrated that electrical stimulation to the spinal cord (i.e. implanted electrodes) can significantly recover bladder, bowel, and sexual function after injury. While promising, a major drawback is that individuals must undergo a highly invasive and expensive surgical procedure to implant the stimulator on top of the spinal cord. Moreover, the inability to re-position the implanted stimulator considerably limits the flexibility of this procedure.
In this project, the investigators propose a comprehensive clinical study examining the effects of TCSCS in promoting recovery of these crucial functions in individuals with SCI. This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.
Electrical neuromodulation has recently emerged as a leader in potential therapies for restoring voluntary control of functional movements in lower limbs after SCI. In addition to functional motor recovery, numerous studies from the investigator's group and collaborators have shown efficacy of both epidural stimulation (invasive) and non-invasive stimulation (TCSCS) in restoring autonomic function. For example, in the investigators preliminary examination of several individuals with SCI, the investigators have demonstrated that epidural stimulation acutely restores cardiovascular control, improves lower urinary tract (LUT) function and reduces time needed for bowel routine. These studies were highly influential in developing stimulation protocols and establishing spinal cord stimulation as a safe and effective therapy. The next logical step is to conduct a wider-scale clinical trial for TCSCS as a novel, efficacious and inexpensive alternative therapy to epidural stimulation. By uniting experts in the field of SCI, physical medicine/rehabilitation, urology, colorectal health and sexual functioning, the investigators are well-equipped to assess TCSCS as a novel means of improving recovery of LUT, bowel and sexual function. The investigator's team has a strong history of collaborative research in these fields and extensive experience in the evaluation of these three aspects of autonomic function using physiological measures/clinical assessments in addition to well-validated questionnaires.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •A participant who meets any of the following criteria will be ineligible to participate:
- •Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to clinically significant renal or hepatic disease; acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications [tricyclics]; or unstable diabetes. The following conditions apply:
- •Moderate and severe forms of renal dysfunctions (eGFR below 60 ml/min)
- •Clinically significant abnormal laboratory tests (ALT; Alkaline Phosphatase; Bilirubin [total]; GGT) as judged by the investigator.
- •Recent treatment with OnabotulinumtoxinA into the detrusor muscle (within 9 months of the baseline visit)
- •Ventilator dependent
- •Clinically significant depression or ongoing drug abuse
- •Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
- •Intrathecal baclofen pump.
- •Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
- •Any implanted metal in trunk or spinal cord under the sites of application of electrodes (between anode and cathode) for those who are allocated to receive TCSCS.
- •Severe anemia (Hgb<8 g/dl) or hypovolemia
- •Participant is a member of the investigational team or his /her immediate family.
- •Participant has undergone electrode implantation surgery.
结局指标
主要结局
Change in resting anorectal pressure determined via anorectal manometry
时间窗: Weeks 4-6
Anorectal manometry will be performed without and with TCSCS to assess the impact of TCSCS on anorectal pressure.
Change in bladder capacity measured by urodynamics
时间窗: Weeks 4-6, Week 19
Changes from baseline during TCSCS (%) in bladder capacity will be calculated. Urodynamics will be performed with and without TCSCS during 3 separate sessions to assess the changes from baseline in the parameters listed above. These measures will be compared to assess reproducibility of changes within urodynamic parameters during TCSCS and after long-term TCSCS.
次要结局
- Surface EMG recording with TCSCS(Weeks 3-4)
- Change in Autonomic Dysfunction following Spinal Cord Injury (ADFSCI) score(Week 1, Week 19)
- Change in Neurogenic Bladder Symptom Score (NBSS)(Weeks 3-4, Week 19, Week 25)
- Change in the International Index of Erectile Function (IIEF) score (for male participants)(Weeks 3-4, Week 19, Week 25)
- Change in the Incontinence Quality of Life (I-QoL) score(Weeks 3-4, Week 19, Week 25)
- Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) score(Week 1, Week 19)
- Change in the Female Sexual Function Index (FSFI) score (for female participants)(Weeks 3-4, Week 19, Week 25)
- Change in Time Needed for Bowel Movement (TNFBM)(Weeks 3-4, Week 19, Week 25)
- Change in Neurogenic Bowel Dysfunction Score (NBDS)(Weeks 3-4, Week 19, Week 25)
- Change in the modified Wexner fecal incontinence score(Weeks 3-4, Week 19, Week 25)
- Change in 24-hour blood pressure monitoring(Weeks 3-4, Week 19)
- Change in subjective sexual function will be measured using semi-structured interview(Week 19)
- Blood pressure will be measured continuously during TCSCS(Weeks 3-18)
研究者
Andrei Krassioukov
Principal Investigator
University of British Columbia