Virtual Reality Treatment for Phantom Limb Pain

NCT ID: NCT03338842

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-12
• Study Completion Date: 2019-11-01

Brief Summary

Patients with limb amputations experience the sensation of the missing extremity, which is sometimes coupled with a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP). This study will test the use of virtual reality (VR) training as a possible treatment of PLP.

Detailed Description

Approximately 90% of patients with limb amputations experience the persistent sensation of the missing extremity, a phenomenon known as phantom limb (PL). Most patients with PL also experience a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP).PLP is often attributed to a disruption of the primary sensory-motor representation, generating "noise" in the representation of the missing extremity, manifesting as pain. If loss of sensory feedback causes degradation of the these cortices, interventions that provide visual feedback about the missing extremity might fine-tune the primary sensory-motor cortices, thereby reducing pain. Within this framework, the present study explores the use of virtual reality (VR) training as a possible treatment of PLP. Twenty-five subjects with lower-limb amputation and chronic PLP will undergo a Virtual Reality (VR) treatment (17 one-hour sessions) consisting in two phases: a Distraction VR phase (5-7 sessions) in which they will explore VR environments using a joystick and a Lower-Limb VR treatment phase (10-12 sessions) in which they will participate in a variety of games and activities using their VR lower-limbs. A comprehensive battery for the assessment of the characteristics, intensity and the daily-life implication of PLP will be presented before and after the treatment and in three follow up testing sessions (1,4, 8 weeks). Furthermore, pain intensity will be assessed before and after each VR session. A dramatic reduction of PLP is expected after the VR treatment and that these beneficial effects remain stable in time.

Conditions

Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Below Knee (Injury); Phantom Limb Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Distractor and Lower limb VR

The training sessions consist of Phase 1 (Distractor VR) in which patients will explore VR environments and Phase 2 (Lower limb VR) in which they will play games using their VR lower-limbs.

Group Type: EXPERIMENTAL

Distractor and Lower limb VR

Intervention Type: DEVICE

In the first phase (A), subjects will receive the Distraction VR treatment during 5, 6, or 7 one-hour-long sessions occurring twice weekly. After the A phase, the remaining sessions (B phase) will consist of Lower-Limb VR treatment. This number includes a mean of 6 (range 5-7) phase A sessions and mean of 11 (range 10-12) phase B sessions.

Interventions

Distractor and Lower limb VR

In the first phase (A), subjects will receive the Distraction VR treatment during 5, 6, or 7 one-hour-long sessions occurring twice weekly. After the A phase, the remaining sessions (B phase) will consist of Lower-Limb VR treatment. This number includes a mean of 6 (range 5-7) phase A sessions and mean of 11 (range 10-12) phase B sessions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects will have undergone amputation of one leg (either above or below the knee) at least 4 months before the enrollment in the study;
• Will have chronic pain in the phantom limb:

Exclusion Criteria

• History of stroke or traumatic brain injury;
• Major active psychiatric illness that may interfere with required study procedures or treatments as determined by the PI on the study, who is a behavioral neurologist;
• Subjects with major medical illness that would be expected to interfere with their ability to complete the study will be excluded.
• Subjects with implanted electronic devices.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Moss Rehabilitation Research Institute

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Branch Coslett

Role: PRINCIPAL_INVESTIGATOR

hbc@mail.med.upenn.edu

Laurel Buxbaum

Role: PRINCIPAL_INVESTIGATOR

Lbuxbaum@einstein.edu

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

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Other Identifiers

823287

Identifier Type: -

Identifier Source: org_study_id