Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- ARM outcome - Rectal sensation
研究概览
简要总结
Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.
详细描述
Time commitment: A person who participates in this study will have the option of coming in for one or two visits (for a total of about 7.5 hours). Descriptions below will separate the research activities into two visits for clarity.
Minimizing barriers to participation:
- - If you live in the region (Cuyahoga, Lorain, Medina, Lake, or Geauga counties of Ohio) and need assistance with transportation to get to and from the research site for a visit, the study team will make these arrangements at no cost to you. If you live outside of the region, the study team will reimburse your transportation expenses up to a maximum of $556 per visit.
- - If you live a distance away from the research site for which it would be easier for you to spend the night closer for a research visit, accessible lodging is available at the Zubizarreta House. This house is right next door to the MetroHealth Rehabilitation Institute and is designed for people with spinal cord injuries. The overnight stay will be provided at no cost to you, but if you need a caregiver to stay with you that is your responsibility.
Visit 1 (screening): When a person decides to participate in the study they will be scheduled to come in for a screening visit. During this visit they will: provide informed consent to participate, participate in the initial screening exams, and have genital nerve stimulation (GNS) applied briefly to determine if the nerve responds to electrical stimulation.
If a person completes the screening procedures and qualifies for the study they will be invited back to complete the manometry 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
- 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
- 否
入选标准
- •Traumatic SCI
- •Minimum 6 months post-injury
- •Aged 18 years or older
- •Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI
- •Response to genital nerve stimulation upon screening
- •Able to understand and provide informed consent
排除标准
- •Currently enrolled in another functional electrical stimulation (FES) research trial
- •Females who are pregnant or planning to become pregnant during the trial
- •Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS.
- •In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.
结局指标
主要结局
ARM outcome - Rectal sensation
时间窗: Up to three weeks after enrollment
Air is infused (50 ml steps) into the ARM balloon until the participant reports: first sensation, urge to defecate, maximum tolerable sensation. The volume of air (cc) is recorded for each sensory event with and without stimulation.
ARM outcome - Anal sphincter function
时间窗: Up to three weeks after enrollment
Circumferential sensors on the ARM balloon catheter will detect pressure changes (cmH20) in the anal sphincter during cough, push, squeeze, and rest. Anal sphincter function will be assessed with and without stimulation.
ARM outcome - Presence of hyper reflexive rectal contractions
时间窗: Up to three weeks after enrollment
After SCI the rectum become hyperreflexive and spastic. A major cause of fecal incontinence after injury is the result of these reflexive contractions and the inability to contract the external sphincter to maintain continence. This combination causes the rectum to expel small amounts of stool rather than storing the material for a larger bowel movement. We will quantify the rectal pressure traces for reflexive contractions and measure their frequency (Hz or count/minute, whichever is most appropriate). Reflexive contractions will be steep increases in rectal pressure while at rest or during distension (sensation and RAIR testing). Measurements will be collected with and without stimulation and compared.
ARM outcome - Rectal wall tension
时间窗: Up to three weeks after enrollment
When an organ relaxes during filling it is called compliance and is characteristic of the rectum and bladder. This allows the organ to hold more material and therefore have a larger void when emptying. After SCI, organs that have had their control systems damaged become spastic and hyperreflexive which leads to smaller volumes and incontinence issues in both bladder and bowel function. By inflating the ARM balloon with air we can slightly distend the rectum and measure the pressure (cmH20) to determine compliance. If the pressure stays the same after inflating the balloon then the rectum has relaxed and it is a measure of compliance. Rectal wall tension will be inferred from this response and abnormal tension will be apparent by reduced compliance (pressure increases when balloon volume increases). This measure will be recorded with and without stimulation.
ARM outcome - Rectoanal reflex activity (RAIR)
时间窗: Up to three weeks after enrollment
Air will be infused into the ARM balloon to distend the rectum. When the rectum is distended the anal sphincter relaxes (rectoanal inhibitory reflex) and the amount of air required to elicit the reflex (cc) will be assessed with and without stimulation.
次要结局
- International SCI Bowel Function Basic Dataset Version 2.1 (ISCI BF BDS)(During enrollment, up to one week)
- SCI Common Data Elements - History of injury(During enrollment, up to one week)
- Clinical exam - abdominal exam(During enrollment, up to one week)
- SCI Common Data Elements - Demographics(During enrollment, up to one week)
- SCI-QOL Bowel Management Difficulties (SCI-QOL BMD)(During enrollment, up to one week)
- International Standards of Neurological Classification of SCI (ISNCSCI)(During enrollment, up to one week)
- Clinical exam - Anal sphincter tone(During enrollment, up to one week)
- Clinical exam - Sensation(During enrollment, up to one week)
- SCI Common Data Elements - Medical history(During enrollment, up to one week)
- Clinical exam - Evaluation of sacral reflexes(During enrollment, up to one week)
- Clinical exam - Voluntary contraction(During enrollment, up to one week)
研究者
Robert Hoey
Associate Professor
MetroHealth Medical Center