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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT04307303
Eligibility Criteria:
* Inclusion Criteria:
* People with a diagnosis of spinal cord injury
* Age =\>18 years of age
* Injury level at or above T12
* complete or incomplete spinal cord lesion
* Medically stable condition
* Reflex bowel
* =\>1 year post spinal cord injury
* Exclusion Criteria:
* A history of organic bowel obstruction
* Frequent opioid use,
* Intrathecal baclofen or percutaneous endoscopic gastrostomy
* Inflammatory bowel disease
* Recent abdominal hernia
* Recent gastrointestinal or abdominal surgery
* Lower motor neuron lesions,
* Suspected strictures or fistulae along the gastrointestinal tract
* Physiologic gastrointestinal obstruction.
* Other causes of constipation such as hypothyroidism, hypercalcaemia
* Constipation predominant irritable bowel syndrome prior to diagnosis of SCI
* Involvement in other research trial interventions likely to impact current trial
* Poorly controlled epilepsy,
* Cardiac pacemaker in situ
* Other implanted electrical devices
* Pregnancy or pregnancy planned
* Cancerous tissue in the abdominal region
* Any major skin disorders affecting the abdominal area)
* Severe autonomic dysreflexia (tested at initial assessment).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04307303
Study Brief:
Protocol Section:
NCT04307303