Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Официальное название

Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Обзор

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.

Подробное описание

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:

1. \- 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. 2. \- 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.

Visit 2 (manometry):

1. \- Preparation: the participant will be asked to complete their typical bowel program the night before their manometry visit is scheduled. There are no restrictions on medications, eating, or drinking prior to the visit. 2. \- Instrumentation: the participant will have the study instrumentation applied. 3. \- Testing procedures with ARM and GNS: The London classification protocol will be used to assess ano-rectal function. This procedure uses a short (\~12 minutes) procedure of actions to determine how the anus and rectum are functioning.

Overall design: GNS and the London classification system will be used to assess bowel function in two different states, with stimulation and without stimulation. This will be applied in the order of no stimulation (condition A), stimulation (condition B), no stimulation (condition A repeated).

Вмешательства

• Устройство Genital Nerve Stimulation
  Electrical stimulation applied to the genital nerve with surface electrodes using an off the shelf TENS unit (Ultima Plus). First, an amplitude threshold for the pudendo-anal reflex responses will be determined. Then, sham (1-2 Hz) and effective stimulation (20 Hz) will be briefly applied to record responses. Then, stimulation will be applied in random presentation order to record any changes in anorectal manometry outcomes due to both sham and effective stimulation.
• Диагностический тест Clinical exam
  Examination by physician determines the presence of pelvic reflexes (pudendo-anal and bulbocavernosus) which are essential for GNS to have an effect.
• Диагностический тест Collection of SCI common data elements
  Data regarding participant demographics, history of injury, and medical history will be collected.
• Диагностический тест Bowel function survey completion
  Two surveys will be conducted to assess the bowel function of the participant. The International SCI Bowel Function Basic Data Set (ISCI BF BDS v2.1) and the SCI Qulaity of Life Bowel Management Difficulties (SCI-QoL BMD) survey scales collect data on overall bowel function and how any difficulties impact the participants quality of life.
• Диагностический тест International Standard for Neurological Classification of SCI (ISNCSCI)
  The physician will conduct the ISNCSCI to determine the level and severity of injury to the spinal cord. This is done by determining the ability to detect light touch and pinprick stimulation. Outcomes will be a Spinal Injury Association Impairment Scale (AIS) grade of A-D.
• Диагностический тест Response to genital nerve stimulation (GNS)
  GNS will be applied to determine if there is a response in the participant. If the participant has no response to the stimulation they will be excluded from the second visit as it is dependent on the ability to respond to GNS.
• Диагностический тест Anorectal Manometry testing (ARM)
  The participant will be instrumented for ARM testing. This requires a special balloon catheter to be inserted into the anus and secured, surface electrode pads being applied to the anal sphincter, and electrode pads being applied to the genital nerve stimulation sites. Once instrumented, the participant will be tested with the London Classification procedure. This procedure asks the participant to perform several actions (squeeze to withhold a bowel movement, push to have a bowel movement, and

Первичные конечные точки

• ARM outcome - Rectal wall tension [Срок оценки: Up to three weeks after enrollment]
• ARM outcome - Anal sphincter function [Срок оценки: Up to three weeks after enrollment]
• ARM outcome - Rectoanal reflex activity (RAIR) [Срок оценки: Up to three weeks after enrollment]
• ARM outcome - Rectal sensation [Срок оценки: Up to three weeks after enrollment]
• ARM outcome - Presence of hyper reflexive rectal contractions [Срок оценки: Up to three weeks after enrollment]

Вторичные конечные точки (11)

• SCI-QOL Bowel Management Difficulties (SCI-QOL BMD) [Срок оценки: During enrollment, up to one week]
• International SCI Bowel Function Basic Dataset Version 2.1 (ISCI BF BDS) [Срок оценки: During enrollment, up to one week]
• International Standards of Neurological Classification of SCI (ISNCSCI) [Срок оценки: During enrollment, up to one week]
• SCI Common Data Elements - Medical history [Срок оценки: During enrollment, up to one week]
• SCI Common Data Elements - History of injury [Срок оценки: During enrollment, up to one week]
• SCI Common Data Elements - Demographics [Срок оценки: During enrollment, up to one week]
• Clinical exam - abdominal exam [Срок оценки: During enrollment, up to one week]
• Clinical exam - Evaluation of sacral reflexes [Срок оценки: During enrollment, up to one week]
• Clinical exam - Anal sphincter tone [Срок оценки: During enrollment, up to one week]
• Clinical exam - Sensation [Срок оценки: During enrollment, up to one week]
• Clinical exam - Voluntary contraction [Срок оценки: During enrollment, up to one week]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• MetroHealth Medical System Old Brooklyn Campus — Cleveland

Идентификаторы

NCT: NCT05626816 · STUDY00000105 · CDMRP-SC210121P1 · CDMRP-SC210121

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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