At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate 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
- 12
- 试验地点
- 2
- 主要终点
- The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
研究概览
简要总结
The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management.
Researchers will:
- Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label
- Compare a target stimulation level to a placebo stimulation level
Participants will:
- Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home
- Visit the research center 3 times to participate in exams and answer questions
- Keep a daily diary of their bowel symptoms and stimulation times
详细描述
The objective of this proposal is to determine how genital nerve stimulation (GNS) acutely modulates neurogenic bowel dysfunction (NBD) in individuals with different severities of spinal cord injury (SCI) and to determine the key study design and methodology parameters of daily at-home administration of GNS. This study will determine the feasibility of daily application of GNS as an intervention for NBD. Key feasibility measures related to dosage and adherence will be evaluated.
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
The data analyst is also masked.
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 of 6 months' post-injury.
- •Aged 18 years and older.
- •Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.
- •Score of 14 or higher on the ISCI BF BDS v2.
- •Response to genital nerve stimulation able to be elicited 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 in the duration of the trial (identified by self-report).
- •Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS.
- •In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.
研究组 & 干预措施
Target genital nerve stimulation
Stimulation waveforms consist of biphasic, charge-balanced square pulses with a pulse width of 0.2 ms and delivered at 20 Hz. Stimuli will be applied over a range of amplitudes to determine the threshold of stimulation for producing reflex contraction of the anal sphincter (the pudendo-anal reflex). Subsequent stimulation will be applied at threshold for the first week, at 1.5 threshold for the second week, and at twice threshold (or max tolerance) for the third and fourth weeks. The typical stimulation range is 20-40 milliamps (mA) and has been shown to be well tolerated by individuals with sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.
干预措施: Genital nerve stimulation (Device)
Sham genital nerve stimulation
Sham stimulation will be applied in the same manner as target stimulation, except that the stimulation frequency will be 1 Hz and the stimulation amplitude will be set to a limit that is at the threshold of perception if individuals have sensation, or 10 mA if they do not have sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.
干预措施: Genital nerve stimulation (Device)
结局指标
主要结局
The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.
时间窗: From baseline to the end of 6 weeks
The 1st feasibility measure bench mark will be the proportion of enrolled who complete the full stimulation protocol.
次要结局
- Anorectal Manometry (ARM)(From baseline to the end of 6 weeks)
- Clinical exam(From baseline to the end of 6 weeks)
- Bowel diary(From baseline to the end of 6 weeks.)
- Stimulation diary(From baseline to the end of 6 weeks.)
- International SCI (ISCI) Bowel Function (BF) Basic Dataset (BDS) version 2.1(From baseline to the end of 6 weeks.)
- SCI-QoL Bowel Management Difficulties (SCI-QoL BMD)(From baseline to the end of 6 weeks.)
- SCI Common Data Elements (CDEs)(At baseline.)
研究者
Kimberly Anderson, PhD
Professor
MetroHealth Medical Center