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Behavioral Intervention
Virtual Reality Treatment for Phantom Limb Pain
N/A
Recruiting
Led By Laurel Buxbaum, PsyD
Research Sponsored by Albert Einstein Healthcare Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capacity to provide Informed Consent
Unilateral above or below knee amputation more than 3 months prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, pre-intervention
Awards & highlights
Study Summary
This trial will compare two treatments for phantom limb pain: one where subjects are engaged in a visually immersive virtual reality experience, and one where subjects play VR games using the virtual rendering of both legs.
Who is the study for?
This trial is for adults aged 18-100 who've had an arm or leg amputated above or below the knee at least 3 months ago, experience significant phantom limb pain (pain in the missing part), and can think clearly enough to consent. It's not for those with major medical issues like stroke, severe brain injuries, uncontrolled mental health conditions, substance abuse problems, or women who are nursing or pregnant.Check my eligibility
What is being tested?
The study tests two virtual reality treatments for phantom limb pain. One distracts patients with immersive VR that doesn't involve moving their legs. The other ('Active VR') has them play games that simulate using both legs. The goal is to see which treatment better eases the pain of a missing limb.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, VR experiences may cause motion sickness, eye strain, disorientation or mild nausea in some individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand and can agree to the study's procedures and risks.
Select...
I had a leg amputation above or below the knee over 3 months ago.
Select...
I am between 18 and 100 years old.
Select...
My phantom limb pain has been over 4 out of 10 for the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre each intervention (8 sessions); immediately after each intervention (8 session); baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre each intervention (8 sessions); immediately after each intervention (8 session); baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in pain intensity
Changes in pain quality
Secondary outcome measures
Pain
Other outcome measures
Therapeutic procedure
Changes in daily activities after the treatment
Changes in depression and anxiety as effect of the treatment
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Distractor VR treatmentExperimental Treatment1 Intervention
Subjects assigned to the Distractor VR treatment will participate in REAL i-Series immersive VR experience (REAL system), which has been demonstrated to reduce pain in several studies but lacks the hypothesized "active ingredients" of our Active VR treatment (visual and auditory feedback of movement of an extrapolated amputated limb). Subjects will navigate through pleasant and relaxing VR environments; they will not see any rendering of their body and make no movements with their legs
Group II: Active VR treatmentExperimental Treatment1 Intervention
Subjects assigned to the Active VR treatment will begin by selecting an avatar, with features such as gender and skin color that can be chosen according to preference. During treatment, they will participate in a variety of games and activities developed and used by our teams including Kick, Dog Food, Quest for Fire, Chess, Checkers, Sudoku, and surfing the internet. Subjects will have substantial flexibility to select games according to their interests but will be required to spend at least 30 minutes in each session in games that require forceful, large amplitude, movements of the amputated lower limb (e.g., Quest for Fire, Kick). Time spent and level of engagement as measured by movements of the avatar or, in the case of chess, checkers, solitaire, Sudoku, and internet surfing, the number of clicks produced with each leg will be recorded for each activity using custom software
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Who is running the clinical trial?
Albert Einstein Healthcare NetworkLead Sponsor
64 Previous Clinical Trials
868,672 Total Patients Enrolled
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,880,048 Total Patients Enrolled
University of WashingtonOTHER
1,739 Previous Clinical Trials
1,847,888 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a serious brain condition, like a severe head injury or stroke.I understand and can agree to the study's procedures and risks.You are currently experiencing major feelings of sadness or worry, as determined by a specific scale.You are currently misusing alcohol or drugs, whether prescribed or not.You must score 18 or higher on a test that measures your memory and thinking skills.I had a leg amputation above or below the knee over 3 months ago.I am between 18 and 100 years old.My phantom limb pain has been over 4 out of 10 for the last month.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Distractor VR treatment
- Group 2: Active VR treatment
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial open to adults over the age of 18?
"The minimum age for inclusion in this trial is set at 18 and the maximum age limit has been established as 100."
Answered by AI
To what extent have participants been incorporated into this clinical trial?
"That is correct. Based on the details provided by clinicaltrials.gov, this medical experiment has been open for recruitment since May 10th 2022 and requires 40 participants across 3 sites."
Answered by AI
What qualifications must potential participants meet in order to be eligible for this clinical research?
"This trial is accepting 40 individuals who have suffered from pain and are between 18 to 100 years of age. The primary requirements for eligibility include the ability to provide informed consent, being at least 3 months removed from a unilateral above or below kneecap amputation, displaying no cognitive impairment (as determined by a score of 24+ on the Montreal Cognitive Assessment), and having had an average phantom limb pain rating greater than 40 over the past month as registered in the McGill Pain Questionnaire (Melzack, 1987)."
Answered by AI
Are recruitment efforts ongoing for this scientific experiment?
"According to information found on clinicaltrials.gov, the trial is still recruiting volunteers. The initial post was made on May 10th 2022 and it has been updated as recently as August 30th of this year."
Answered by AI
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