RecruitingNot ApplicableNCT07044323

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

Sponsor

Albert Einstein Healthcare Network

Enrollment

44 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

Amputation Phantom Pain Following Amputation of Lower Limb

Summary

After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. The study will explore the feasibility and efficacy of a home-based, active VR treatment for phantom limb pain (PLP).

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria5

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 Criteria5

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

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Interventions

BEHAVIORALActive Virtual Reality Treatment

The self-administered active VR treatment will consist of 8 twice-weekly sessions, each approximately 1 hour in duration, during which subjects will participate in a variety of Virtual Reality active games that require leg movements while receiving high-quality visual feedback of the missing lower leg.