BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Neuromodulation for Ulcerative Colitis
General Information:
The objective of the BOOM-IBD2 clinical trial is to evaluate the effectiveness of an investigational nerve stimulation (neuromodulation) device for ulcerative colitis (UC). This treatment involves implanting a small electronic device that delivers mild electrical pulses to a nerve near the tailbone. The study will assess the impact of this therapy on bowel urgency, quality of life, inflammation, and other measures over a 12-month period through a combination of in-person and virtual visits.
Eligibility:
Inclusion Criteria:
● Male or female
● 18 to 85 years of age
● Diagnosed with ulcerative colitis
● Ability and willingness to consent to participate by signing the informed consent form
● Ability to comply with the protocol and willingness to comply with all follow-up requirements
Exclusion Criteria:
● Crohn's disease, indeterminate colitis/inflammatory bowel disease-unclassified
● Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
● Any psychiatric or personality disorder at the discretion of the study investigator
● Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
● Active clostridium difficile infection of the colon
● Active cytomegalovirus (CMV) infection of the colon
● Evidence of colonic perforation
● Fulminant colitis requiring emergency surgery
● Microscopic, ischemic or infectious colitis
● Unresected neoplasia of the colon
● Colonic stricture unable to pass a colonoscope
● Current evidence of cancer in the gastrointestinal tract
● Current participation in another clinical trial
● Previous history of surgery for ulcerative colitis
● Previously implanted with a neurostimulation device or participated in a neurostimulation trial
● Inability to operate the patient programmer
Study Details:
Study description/explanation of participation:
The investigational nerve stimulation (neuromodulation) device is implanted in an outpatient procedure and delivers mild electrical pulses to a nerve near the tailbone. The study will last 12 months following implantation, involving 6 in-person visits and 4 virtual visits. Throughout this 12-month period, the patient will be monitored to assess the device's effectiveness.
Patient Participation Requirements:
6 in-person visits, 4 virtual visits with the following surveys/questionnaires: EQ-5D-5L Questionnaire, IBDQ, Electronic Urgency Numeric Rating Scale (UNRS), Patient Simple Ulcerative Colitis Clinical Activity Index, Work Productivity and Activity Impairment Questionnaire-UC (WPAI-UC)
Possible risks and side effects:
Potential risks of surgical implantation include, but are not limited to:
● Adverse change in bowel or urinary function
● Allergic or immune response to the implanted materials that could result in device rejections
● Change in sexual function
● Cyst
● Depression
● Device complications (e.g. device failure/malfunction; lead fracture; lead/neurostimulator migration, dislodgement, or erosion; reoperation/revision)
● Fever
● Implant site complications (e.g. dehiscence [failure of wound to heal]; discharge; ecchymosis [discoloration of skin due to bleeding beneath]; effusion [escape of fluid]; erosion; erythema [reddening of the skin]; hematoma [pooling of blood outside of a blood vessel]; hemorrhage; infection; irritation; pain; paresthesia [burning or prickling sensation, usually in the hands or feet]; seroma [a buildup of fluids where tissue has been removed])
● Infection
● Inflammation
● Insomnia
● Lack of effective therapy or loss of therapeutic effect resulting in return of baseline symptoms
● Nausea/ vomiting
● Neuromuscular complications (e.g. muscle spasms and contractions; changes in voluntary movement)
● New pain
● Skin complications (e.g. itching, rash, discoloration)
● Stimulation/sensation complication (e.g. change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or shocking) by some patients; unintended nerve activation)
● Suspected nerve injury
● Transient electrical shock
● Tenderness/ discomfort
● Weakness