Spinal Cord Injury
Conditions
Keywords
fecal incontinence, neurogenic bowel, tetraplegia, paraplegia, paralysis, electrical stimulation, neuromodulation, bowel, feasibility, anorectal manometry
Brief summary
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
Detailed description
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.
Interventions
Genital nerve stimulation (GNS) will be administered via non-invasive surface skin electrodes. In men, two surface electrodes (1 cm diameter) will be placed on the dorsum of the penile shaft 2 cm apart. In women, one surface electrode will be placed near the clitoris and a second surface electrode will be placed on the labia majora or inner thigh. The electrodes will be connected to an electrical stimulator device.
Sponsors
Congressionally Directed Medical Research Programs
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Traumatic SCI. 2. Minimum of 6 months' post-injury. 3. Aged 18 years and older. 4. Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI. 5. Score of 14 or higher on the ISCI BF BDS v2.1. 6. Response to genital nerve stimulation able to be elicited upon screening. 7. Able to understand and provide informed consent.
Exclusion criteria
1. Currently enrolled in another functional electrical stimulation (FES) research trial. 2. Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report). 3. 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. 4. In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anorectal Manometry (ARM) | From baseline to the end of 6 weeks | The main secondary endpoint will be anorectal reflex activity as measured by ARM. ARM is the gold standard clinical tool for investigating anorectal function. It is widely available and very well established. Recent efforts have been made to standardize ARM testing protocols so that results can be categorized. The London Classification protocol will be used in ARM testing in this experiment. |
| Clinical exam | From baseline to the end of 6 weeks | This is conducted by a clinician and involves a gastrointestinal system clinical exam of bowel dysfunction. |
| Bowel diary | From baseline to the end of 6 weeks. | A bowel diary is a means for participants to record daily bowel activities. It will be time-stamped. Parameters that are targeted to be recorded include stool type (using the Bristol Stool Scale), amount, planned emptying episodes (including time), incontinence episodes, sense of urgency, straining, medications, and complications such as nausea or hemorrhoids. These data will characterize each participant's bowel management routine, daily habits, and gastrointestinal (GI) symptoms. |
| Stimulation diary | From baseline to the end of 6 weeks. | A record of hours of daily stimulation use will also be captured in a stimulation diary. |
| SCI-QoL Bowel Management Difficulties (SCI-QoL BMD) | From baseline to the end of 6 weeks. | The SCI-QoL BMD measures difficulties people living with SCI have with bowel management, including feelings of distress associated with bowel problems they experience in daily life. The items focus on issues related to fecal incontinence and the psychosocial consequences of fecal incontinence, which is different that the ISCI BF BDS v2.1 and why it was selected as an additional secondary outcome measure. The full scale is composed of 26 items, but a computer assisted technology version and 9-item short form version have also been created. The short form version will be used in this trial and is available for download from Assessment Center. Each item has a response option based on a 5-point Likert scale ranging from 1 'never/not at all' to 5 always/very much'. Raw scores range from 9-45 with higher scores representing greater difficulty managing bowel problems. |
| SCI Common Data Elements (CDEs) | At baseline. | SCI CDEs to be collected include 1) Medical History for body system categories including start date, end date, and ongoing status, 2) History of Injury (injury time frame, injury etiology), 3) Demographics (gender, birth date, race, ethnicity, marital status, number of members in household, area of residence, number of years of education, primary occupation), and 4) International Standards for Neurological Classification of SCI for injury classification (upper extremity motor score, lower extremity motor score, total motor score, light touch sensory score, pinprick sensory score, deep anal pressure, voluntary anal contraction, zone of partial preservation, and impairment grade data) |
| International SCI (ISCI) Bowel Function (BF) Basic Dataset (BDS) version 2.1 | From baseline to the end of 6 weeks. | The ISCI BF BDS v2.1 incorporates the Neurogenic Bowel Dysfunction Score as well as information about GI or anal sphincter dysfunction unrelated to SCI, surgical procedures on the GI tract, defecation methods and bowel care procedures, the need to wear external continence products, and presence of abdominal pain or discomfort. The NBDS was developed specifically for SCI and measures the degree of neurogenic bowel dysfunction symptomology and the impact on quality of life (QoL). There are 10 items, and they are symptom-based and weighted by the impact on QoL. The score ranges from 0-45 with a higher score meaning a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment questionnaire | At the end of 6 weeks. | It is important to be able to collect participant feedback on the ease or difficulty of using the TENS unit and applying GNS at home. This is important feasibility information that should be collected, and we will generate a form to enable more standardized collection of this data from each participant. This will include prompts such as any difficulty placing electrodes, any difficulty keeping electrodes in place, any need for further training on the device once home, any device malfunctions, any need for replacement components or electrodes, etc. |
| Study exit questionnaire | At the end of 6 weeks. | A study exit questionnaire will be used to determine whether participants remained blinded throughout the study and any perspectives on their experience while in the study. |
Countries
United States
Contacts
Primary ContactMayson Moore
Backup ContactMegan Hammond Nechols
Outcome results
None listed