The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
The purpose of this study is to see how well the Vibrant capsule works at treating people with spinal cord injury (SCI)-induced upper motor neuron (UMN) neurogenic bowel. This study will test the safety of the Vibrant capsule. This Vibrant capsule has been approved by the Food and Drug Administration (FDA) for chronic idiopathic constipation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The 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.
TIRR Memorial Hermann
Houston, Texas, United States
RECRUITINGSafety 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 4
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 treatment
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 4
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 treatment
Safety as assessed by average weekly Numerical Pain Score
The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.
Time frame: baseline week 1, baseline week 2, baseline week 3, baseline week 4
Safety as assessed by average weekly Numerical Pain Score
The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.
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 treatment
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Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)
The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.
Time frame: baseline, week 3
Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)
The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.
Time frame: week 1 with treatment, week 4 with treatment, week 8 with treatment
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 treatment
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)