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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days
Awards & highlights
Study Summary
This trial will test whether virtual reality can help reduce pain and anxiety during a medical procedure.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
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 moreTrial 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
~1630
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.
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.
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Who is running the clinical trial?
Gillette Children's Specialty HealthcareLead Sponsor
30 Previous Clinical Trials
11,453 Total Patients Enrolled
Chantel Barney, PhDPrincipal InvestigatorGillette Children's Specialty Healthcare
1 Previous Clinical Trials
48 Total Patients Enrolled
Chantel Burkitt, PhDPrincipal InvestigatorGillette Children's Specialty Healthcare
1 Previous Clinical Trials
500 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I will be fully asleep during my medical procedure.You have experienced motion sickness in the past.I have epilepsy.You have a device called a ventricular shunt.I will have surgery during the study.You are currently getting botulinum toxin injections at Gillette Children's Specialty Healthcare.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Reality for distraction
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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