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 research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to enhance pain treatment for patients with IBD. The study hypothesis include: * the study will achieve greater than 75% program completion and 75% study assessment completion * patients with IBD will find VR-directed BGBT acceptable as an outpatient pain treatment * outpatient VR-directed BGBT in IBD arm participants will report a greater reduction in pain scores, symptom burden, stress, depression, anxiety, and pain-related interference and an improvement in health-related quality of life * will have lower opioid requirements and healthcare utilization at 4-weeks follow-up compared to the E-TAU arm

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.

How is VR-directed BGBT treatment different from other treatments for inflammatory bowel disease?

VR-directed BGBT is unique because it uses virtual reality to create an immersive experience that can help relieve abdominal pain, which is a common symptom in disorders of gut-brain interaction. Unlike traditional treatments that may have side effects or provide incomplete relief, this approach leverages technology to potentially improve symptoms and quality of life without the need for medication. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment VR-directed BGBT for Inflammatory Bowel Disease?

Research shows that virtual reality (VR) therapy can help manage pain and reduce mental distress in various conditions, such as burn rehabilitation and pain management. This suggests that VR-directed BGBT might also be effective in alleviating symptoms associated with Inflammatory Bowel Disease. ^{6 7 8 9 10}

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 do not experience significant pain.

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

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

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]

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]

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. United States pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality in Burn Rehabilitation: A Systematic Review and Meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Time-Dose-Matched Virtual Reality Therapy on Upper Limb Dysfunction in Patients Poststroke: A Meta-Analysis of Randomized Controlled Trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Addressing virtual reality misclassification: A hardware-based qualification matrix for virtual reality technology. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Computational postprocessing quantification of small bowel motility using magnetic resonance images in clinical practice: An initial experience. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Global small bowel motility: assessment with dynamic MR imaging. [2022]