Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT04627168
Eligibility Criteria:
Inclusion Criteria:
* For spinal cord injury subject group:
* Traumatic or non-traumatic spinal cord injury;
* Constipation;
* Motor-complete or motor-incomplete spinal cord injury;
* Quadriplegia or paraplegia;
* Post-injury time ≥ 1 year;
* Neurogenic Bowel Dysfunction Score ≥ 7.
* For able-bodied subject group:
* Diagnosis of intestinal constipation according to the Rome IV criteria;
* Chronic constipation as defined by \< 3 bowel movements per week for \> 3 months.
* For both subject groups:
Can read, understand and willingly sign an Institutional Review Board approved informed consent document that describes the study's risks and benefits.
Exclusion Criteria:
1. Presence of any organic cause for intestinal constipation;
2. Have chronic fecal incontinence;
3. Have skin infection/lesion in the area of electrode application or systemic skin disease;
4. Have an implanted electronic device (such as heart pacemaker, insulin or baclofen pump, etc);
5. Have symptomatic cardiac disease;
6. Have uncontrolled diabetes;
7. Presence of abdominal hernia;
8. Have a stoma, rectal tear, or untreated hemorrhoids;
9. Have a significant psychiatric disorder;
10. For female subjects, being pregnant, actively planning a pregnancy or breast-feeding a child;
11. Be participating in another clinical study that would confound data analysis;
12. Have a cognitive impairment or exhibits any characteristic that would limit the study candidate's ability to complete study assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04627168
Study Brief:
Protocol Section:
NCT04627168