What side effects are associated with this type of intervention?

Common treatments for muscle spasms include repetitive transcranial magnetic stimulation (rTMS) and virtual reality-based therapies. rTMS is generally well tolerated but can cause side effects such as lightheadedness, tingling, and tinnitus. Virtual reality-based therapies, used for distraction and sensory immersion, are typically safe but may occasionally lead to mild discomfort or motion sickness. Both treatments require further research to confirm their efficacy and safety profiles.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for muscle spasms, including medications such as baclofen, tizanidine, and diazepam, which act as muscle relaxants. Non-pharmacological treatments like physical therapy and neuromodulation techniques, such as transcutaneous electrical nerve stimulation (TENS), have also been utilized. While virtual reality-based interventions for muscle spasms are still under investigation, they represent a novel approach focusing on distraction and sensory immersion to potentially alleviate pain and improve motor function.

What other types of research exist?

Promising novel alternatives to Virtual Reality for treating muscle spasms in 2024 include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown some positive findings but requires more robust trials for confirmation. 2) Spinal Cord Stimulation (SCS), particularly high-frequency and burst SCS, which have demonstrated efficacy in managing chronic pain and could be adapted for muscle spasms. 3) A software application designed for spasticity management in multiple sclerosis patients, which has shown significant improvement in spasticity scores.

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Virtual Reality for Muscle Spasms

N/A

Waitlist Available

Led By Chantel Barney, PhD

Research Sponsored by Gillette Children's Specialty Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Patients who are fully anesthetized during their medical procedure

Patients with epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using Virtual Reality can reduce pain and anxiety during botulinum toxin injections. VR aims to distract patients by immersing them in a virtual world, making the procedure less uncomfortable. Immersive virtual reality (VR) has shown efficacy in treatment of procedural discomfort in pediatric patients receiving botulinum toxin injections for spasticity.

Who is the study for?

This trial is for patients at Gillette Children's Specialty Healthcare who are getting botulinum toxin injections. It's not for those who will be fully anesthetized, don't speak English, have surgery scheduled during the study, suffer from epilepsy or motion sickness, or have a ventricular shunt.

What is being tested?

The trial tests if using Virtual Reality during painful medical procedures like botulinum toxin injections can reduce pain and anxiety compared to standard care. Participants are randomly chosen to receive VR or standard care while being observed.

What are the potential side effects?

Since this trial involves Virtual Reality, side effects may include discomfort such as dizziness or nausea related to motion sickness but generally should be minimal.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I will be fully asleep during my medical procedure.

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I have epilepsy.

Select...

I will have surgery during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Secondary study objectives

A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR.

Information collected from the medical record (e.g., medication use during procedure).

Pain

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality for distractionExperimental Treatment1 Intervention

The application of VR during the putative painful treatment (botulinum toxin injections) will provide a) active and engaging distraction during the procedure, and will b) block the view and auditory noise related to the procedure.

Group II: Standard of CareActive Control1 Intervention

Patients will receive the standard of care for the putative painful treatment (botulinum toxin injections).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality

2017

Completed Phase 3

~1580

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for muscle spasms, such as Virtual Reality (VR) therapy, repetitive transcranial magnetic stimulation (rTMS), transcutaneous electrical nerve stimulation (TENS), and vibratory stimulation, work by modulating neural activity to reduce muscle hyperactivity. VR therapy uses distraction and sensory immersion to engage the brain and reduce the perception of pain and discomfort. rTMS and TENS apply electromagnetic and electrical stimuli, respectively, to alter neural circuits and decrease spasticity. Vibratory stimulation leverages mechanical vibrations to influence muscle tone and motor control. These mechanisms are important for muscle spasm patients as they can significantly alleviate pain, improve functional mobility, and enhance overall quality of life.

Vibratory stimulation. Part III. Possible applications of vibration in treatment of motor dysfunctions.Effects of a Virtual Reality-Based Mirror Therapy Program on Improving Sensorimotor Function of Hands in Chronic Stroke Patients: A Randomized Controlled Trial.Comparison of the effect of focused and radial extracorporeal shock waves on spastic equinus in patients with stroke: a randomized controlled trial.