NCT06956508

Prophylactic TBR on Phantom Limb Pain

Assessing the Impact of Prophylactic Targeted Brain Rehabilitation (TBR) on Phantom Limb Pain in the Perioperative Period Following Major Amputation, A Prospective Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: OrthoCarolina Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

This prospective study seeks to evaluate the effectiveness of prophylactic Targeted Brain Rehabilitation (TBR) in preventing or reducing Phantom Limb Pain (PLP).

Detailed description

Phantom limb pain (PLP) affects 60-80% of amputees, including both upper and lower extremity amputees, leading to increased anxiety, depression, and reduced quality of life. With the total prevalence of major limb amputees in the United States projected to reach 3 million by 2050 and approximately 185,000 new cases annually, there is a pressing need for effective interventions to prevent and manage PLP. Current pharmacologic treatments offer limited relief and can lead to adverse outcomes, particularly with long-term opioid use. Non-pharmacologic alternatives, such as mirror therapy, lack strong evidence supporting their efficacy and, to our knowledge, have not been evaluated in the perioperative period. Virtual reality (VR) has emerged as a promising tool for mitigating various aspects of the phantom limb experience in major limb amputees. Previous research has shown that VR treatments can significantly reduce PLP, with many studies reporting a drop in numeric pain scores after VR use, and can be cost-effective. However, current literature on VR therapy for PLP has never evaluated its use in the immediate post operative period. Initiating VR therapy immediately post-amputation may help in preventing maladaptive cortical reorganization, which is believed to be a key factor in the development of PLP. Following amputation, the sensory-motor cortex undergoes rapid rewiring as the brain attempts to compensate for the loss of sensory input from the amputated limb. This reorganization can lead to the formation of aberrant neural connections, contributing to the perception of phantom limb sensations and pain. By providing a virtual representation of the missing limb and facilitating its movement, VR therapy may be able to help maintain the integrity of the sensory-motor cortex, potentially preventing or reducing the development of PLP. Our research team hypothesizes that prophylactic use of Targeted Brain Rehabilitation (TBR), a VR-based therapy system, in the perioperative period following major amputation can prevent or reduce the development of PLP and decrease the usage of opioids in this population. Furthermore, introducing VR therapy in the immediate post-operative period could help mitigate the psychological distress associated with amputation. By addressing both the physical and psychological aspects of amputation from the outset, prophylactic VR therapy has the potential to significantly improve the quality of life for amputees and reduce the long-term burden of PLP. Establishing the efficacy of prophylactic TBR in the perioperative period could revolutionize the standard of care for amputees, potentially reducing the incidence and severity of PLP and its associated psychological and quality of life impacts. This study will lay the groundwork for future multi-center, randomized controlled trials to validate the effectiveness of prophylactic TBR and establish it as a potential standard of care for amputees.

Conditions

• Phantom Limb Pain After Amputation

Interventions

Type	Name	Description
OTHER	Targeted Brain Rehabilitation	Patients will be given a virtual reality headset that is pre-loaded with the targeted brain rehabilitation (TBR) software at the time of their major amputation. The Virtual Reality (VR) environment will consist of a high-fidelity virtual representation of the participant's phantom limb. Participants will use a mounted head display (MHD) to interact with a virtual avatar, with the phantom limb represented as a realistic 3D limb model matching the remaining anatomy and skin tone. The VR system will be set up either in the clinic or at the participant's home, depending on individual circumstances and preferences. The VR protocol will be standardized and include exercises designed to mimic typical occupational therapy session.

Timeline

• Start date: 2026-02-05
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-05-04
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States