Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorThe University of Texas Health Science Center, Houston
About this trial
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals with chronic spinal cord injury (SCI) of more than one year.
Stable neurological level and function of SCI for at least six months.
Consistent bowel program without changes for at least 3 months.
At least one scheduled bowel movement (BM) every three days.
Disqualifiers
Bowel incontinence occurring more than once per week.
Non-English-speaking individuals.
History of bowel obstruction, ileus, diverticulitis, or bowel surgery for a disease (appendix removal is ok).
Persistent autonomic dysreflexia (AD) triggered by bowel movements.
Trial design
Design model
Single group
Treatments tested in this trial
Vibrant Capsule
DeviceThe Vibrant capsule is designed to alleviate chronic constipation by stimulating the colon through gentle vibrations. The Vibrant capsule will be swallowed and tracked through the digestive system of spinal cord injury patients.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Vibrant CapsuleExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of Vibrant capsule as indicated by number of participants who had an adverse event
Time frame
baseline week 1, baseline week 2, baseline week 3, baseline week 42
Safety of Vibrant capsule as indicated by number of participants who had an adverse event
Time frame
week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment, week 5 with treatment, week 6 with treatment, week 7 with treatment, week 8 with treatment3
Safety of Vibrant capsule as assessed by the Penn Spasm Frequency Scale (PSFS)
The total score on the Penn Spasm Frequency Scale (PSFS) ranges from 0 to 7, and a higher score indicates greater spasm frequency and severity.
Time frame
baseline week 1, baseline week 2, baseline week 3, baseline week 44
Safety of Vibrant capsule as assessed by the Penn Spasm Frequency Scale (PSFS)
The total score on the Penn Spasm Frequency Scale (PSFS) ranges from 0 to 7, and a higher score indicates greater spasm frequency and severity.
Time frame
week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment, week 5 with treatment, week 6 with treatment, week 7 with treatment, week 8 with treatmentSecondary outcomes
1
Feasibility as indicated by the number of participants that adhere to the prescribed use of Vibrant
Feasibility of the Vibrant capsule will be recorded in this patient population by adherence to the protocol.
Time frame
from week 1 with treatment to week 8 with treatment2
Feasibility of using the Vibrant capsule as indicated by a satisfaction survey
Feasibility will also be recorded by a satisfaction survey completed by the study participant. Total score ranges from 0 to 40, with a higher score indicating higher satisfaction.
Time frame
end of study (8 weeks after start of treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
Mission Connect
Collaborator
Source ClinicalTrials.gov