Virtual Reality Therapy for Inflammatory Bowel Disease

Overseen By Shirley Cohen-Mekelburg, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: IBD-targeted treatment

Disqualifiers: Seizures, Pregnancy, Cardiac, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can reduce pain for individuals with inflammatory bowel disease (IBD). Participants will determine if VR, combined with a specific pain management technique called VR-directed BGBT (biofeedback-guided breathing therapy), improves their quality of life and reduces symptoms such as stress and anxiety. The study compares the VR treatment to the usual care patients receive. Ideal candidates are those with IBD who experience regular abdominal pain and can pick up and return VR equipment at the University of Michigan. As an unphased trial, this study offers participants the chance to explore innovative pain management techniques that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be receiving IBD-targeted treatments like 5-aminosalicylates, thiopurines, biologics, or small molecules, so it seems you can continue these medications.

What prior data suggests that this VR-directed BGBT program is safe for patients with IBD?

Research has shown that virtual reality (VR)-guided brain-gut therapy has primarily been tested for practicality and acceptability in people with inflammatory bowel disease (IBD). Studies have assessed patient completion rates and their opinions on the therapy as a treatment option.

In earlier research, patients used VR-guided therapy in the hospital, and most found it manageable. No major safety issues were reported, and most patients accepted the experience. However, detailed information about side effects or specific safety results is not widely available in current studies.

This trial tests VR-guided therapy for patients outside the hospital. Given its positive reception in hospitals, it may also be safe for home use. Staying informed and discussing any concerns with the study team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VR-directed BGBT for Inflammatory Bowel Disease (IBD) because it offers a unique, non-drug approach to managing symptoms. Unlike traditional treatments like anti-inflammatory medications or immunosuppressants, this therapy uses virtual reality to guide biofeedback and gut-brain training, potentially reducing stress-related flare-ups. This innovative method targets the gut-brain axis, aiming to improve IBD symptoms by modulating the stress response, which is a novel mechanism compared to standard treatments. Plus, the use of virtual reality makes therapy more engaging and accessible, potentially improving patient adherence and outcomes.

What evidence suggests that VR-directed BGBT is effective for IBD?

Research has shown that Virtual Reality (VR) in Brain Gut Behavioral Treatment (BGBT) might help individuals with Inflammatory Bowel Disease (IBD) manage pain more effectively. In this trial, participants will receive either VR-directed BGBT or Enhanced Treatment as Usual (E-TAU). The VR-directed BGBT uses VR to enhance therapy that improves brain-gut communication, often problematic in IBD. Early results suggest that patients find this method practical and acceptable. Some studies have demonstrated that VR therapy can reduce pain and improve quality of life. While more data is needed to confirm its effectiveness specifically for IBD, this approach appears promising based on its innovative use of VR in similar conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

Shirley Cohen-Mekelburg, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with Inflammatory Bowel Disease (IBD) who are interested in a virtual reality-based therapy to manage pain. Specific eligibility criteria details were not provided, so participants should inquire about any additional requirements.

Inclusion Criteria

I can pick up and return VR equipment at UM.

I have had abdominal pain with an average severity of 2 or more in the last day.

I am an adult with IBD and am receiving treatment for it.

Exclusion Criteria

I don't have conditions like epilepsy, severe heart issues, or pregnancy that VR could worsen.

I do not experience significant pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week VR-directed BGBT program to enhance pain treatment for IBD

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of opioid requirements and healthcare utilization

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VR-directed BGBT

Trial Overview The study tests if VR-directed Brain-gut Behavioral Therapies (BGBT) can help reduce pain and improve quality of life for IBD patients compared to standard treatment. Success will be measured by program completion rates and improvements in pain scores and health-related quality of life.

How Is the Trial Designed?

Group I: VR-directed BGBT Experimental Treatment 1 Intervention

Group II: Enhanced treatment as usual (E-TAU) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

American Gastroenterological Association

Collaborator

Trials

6

Recruited

4,400+

Published Research Related to This Trial

In a study involving 20 stroke survivors, multiuser virtual reality (MU VR) therapy led to significantly greater arm movement (414.6m) compared to single-user (SU VR) therapy (327.0m), indicating that MU VR may enhance physical engagement during rehabilitation.

Participants showed high compliance with both therapy modes (99% for MU and 89% for SU), and overall motor recovery, as measured by the Fugl-Meyer Assessment, improved significantly across all participants, suggesting that MU VR can effectively extend clinical therapy into home settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. Thielbar, KO., Triandafilou, KM., Barry, AJ., et al.[2020]

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

Disorders of gut-brain interaction (DGBIs), such as functional dyspepsia and irritable bowel syndrome (IBS), are common and significantly impact patients' quality of life, highlighting the need for effective treatments.

Recent studies suggest that virtual reality (VR) technology may be a promising novel therapy for alleviating chronic abdominal pain associated with DGBIs, potentially offering a non-invasive alternative to traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? Lacy, BE., Cangemi, DJ., Spiegel, BR.[2023]

Virtual reality (VR) rehabilitation significantly improves quality of life and work performance in burn patients, with a notable increase in range of motion (ROM) of joints (SMD=0.72) compared to usual rehabilitation methods.

VR interventions effectively reduce various aspects of pain (intensity, affective, and cognitive components) and lower anxiety levels during treatment, while also making rehabilitation more enjoyable, although they do not significantly enhance hand grip or pinch strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality in Burn Rehabilitation: A Systematic Review and Meta-analysis. Lan, X., Tan, Z., Zhou, T., et al.[2023]

Active virtual reality (VR) therapy significantly improved symptoms of functional dyspepsia compared to sham VR, with a notable mean difference in symptom severity scores over a 2-week period.

The study found that VR was safe, with only one patient withdrawing due to nonserious adverse effects, suggesting it could be a beneficial treatment option for managing dyspepsia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. Cangemi, DJ., Montenegro, M., Spiegel, BMR., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06188793

NCT06188793 | Virtual Reality (VR) -Directed Brain Gut ... Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients. ClinicalTrials.gov ID NCT06188793.

2. withpower.com withpower.com/trial/phase-inflammatory-bowel-diseases-2024-e1138

Virtual Reality Therapy for Inflammatory Bowel Disease Virtual Reality-Directed Brain Gut Behavioral Treatment is unique because it uses virtual reality (VR) to enhance the effectiveness of behavioral therapy, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40615149/

Evaluation of a virtual reality-directed brain-gut behavioural ... In this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12226949/

Evaluation of a virtual reality-directed brain-gut behavioural ... In this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/605135

Outpatient VR (Virtual Reality)-Brain-gut Behavioral ... This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06910787

NCT06910787 | Outpatient VR (Virtual Reality)-Brain-gut ... Outpatient Virtual Reality-Directed Treatment for Pain in Inflammatory Bowel Disease. Conditions. Inflammatory Bowel Diseases. Inflammatory Bowel Diseases.