Home-based virtual reality treatment for phantom leg pain

Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain.Home-Based Treatment

This program will test whether a home-based active virtual reality treatment can reduce phantom leg pain for adults after a lower-limb amputation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Albert Einstein Healthcare Network (other)
• Locations: 3 sites (Philadelphia, Pennsylvania and 2 other locations)
• Trial ID: NCT07044323 on ClinicalTrials.gov

What this trial studies

Adults with unilateral above- or below-knee amputations and persistent phantom limb pain will use an active virtual reality program at home that displays a first-person avatar leg and provides controller-based positional feedback while they play leg-moving games. Participants will be enrolled at sites in Philadelphia and Seattle and will use the home VR system for a defined treatment period with pain intensity, psychological health, and quality-of-life measures collected remotely. The active VR approach provides visual and sensorimotor feedback of the missing limb to encourage movement and cortical engagement, unlike distractor VR which offers passive navigation without limb representation. Investigators previously completed an in-person comparison in which active VR produced greater reductions in pain intensity than distractor VR.

Who should consider this trial

Good fit: Ideal candidates are adults (18+) with a unilateral above- or below-knee amputation at least three months prior, who report average phantom limb pain greater than 4/10 and can complete cognitive testing (MoCA ≥18) and home VR activities.

Not a fit: People with bilateral amputations, significant cognitive impairment, uncontrolled psychiatric illness or substance abuse, current pregnancy, or lower average phantom pain (≤4/10) are unlikely to qualify or receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the home-based active VR program could reduce phantom limb pain and improve daily functioning without adding medications or invasive procedures.

How similar studies have performed: Prior in-person research by the investigators and other small trials have shown that active, body-representing VR can reduce phantom limb pain, but home-based delivery remains less tested.

Eligibility criteria

Inclusion Criteria:

* Age 18 -100
* Capacity to provide Informed Consent
* Unilateral above or below knee amputation more than 3 months prior to enrollment
* Absence of cognitive impairment, operationally defined as a Montreal Cognitive Assessment score of 18 or greater1.
* Pain averaged over the preceding 1 month in the phantom limb rated as greater than 4 on a scale of 0-10.

Exclusion Criteria:

* History of significant medical or neurological disorder such as stroke or moderate to severe traumatic brain injury (operationally defined as loss of consciousness for more than 30 minutes)
* History of significant or poorly controlled psychiatric disorders
* Substantial depression or anxiety affecting their ability to perform tasks necessary for the study.
* Current abuse of alcohol or drugs, prescription or otherwise
* Nursing a child, pregnant, or intent to become pregnant during the study

Where this trial is running

Philadelphia, Pennsylvania and 2 other locations

• Jefferson Moss Rehabilitation Research Institute — Philadelphia, Pennsylvania, United States (RECRUITING)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
• University of Washington — Seattle, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Laurel Buxbaum

Conditions: Phantom Pain Following Amputation of Lower Limb, Amputation, pain, phantom limb, lower limb amputation, treatment