Clinical trial NCT05915065: VR to Evaluate Phantom Limb Pain
Official title: Intuitively Controlled Virtual Reality to Treat Phantom Limb Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Phantom Limb Pain
Phantom Pain
Phantom Sensation
Phantom Limb Syndrome With Pain
Phantom Pain Following Amputation of Lower Limb
Phantom Pain Following Amputation of Upper Limb
Amputation
Upper Limb Amputation at the Hand
Upper Limb Amputation at the Wrist
Upper Limb Amputation Below Elbow (Injury)
Upper Limb Amputation Above Elbow (Injury)
Lower Limb Amputation Knee
Lower Limb Amputation Above Knee (Injury)
Lower Limb Amputation Below Knee (Injury)
Lower Limb Amputation at Ankle (Injury)
Keywords: Virtual Reality
Limb Loss
Amputation
Phantom Pain
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Coapt, LLC
First posted: 2023-06-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will enroll one, non-random group of amputees to participate in 2-4 in person or virtual research visits, participate in a home trial and complete questionnaires pre home trial, at various points during the home trial and upon conclusion of the home trial.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation.

We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.

Detailed description: The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity limb absence.

Phase 1: Complete in-lab or virtual iterative usability and functionality testing of hardware and software components of The Coapt Phantom Limb Pain Management System to ensure readiness for at-home use - COMPLETED

Phase 2: A clinical trial of The Coapt Phantom Limb Pain Management System during at-home use. We hypothesize that the system will improve PLP for individuals with upper or lower extremity absence, as measured through various questionnaires.

VR systems have been proposed as alternative technologies to treat PLP since they are relatively inexpensive and more readily available. Virtual reality environments allow for real-time control practice utilizing different tasks and games, and have been widely accepted as clinically viable options for administering therapy.

Effective PLP treatment methods are needed for individuals with limb absence that can be utilized on an as-needed basis in the home. VR therapy could potentially be an effective treatment for individuals with chronic upper or lower limb PLP.

Eligibility criteria: Inclusion Criteria:

* Adults over the age of 18 years old
* Amputation of the upper or lower limb, including amputation of multiple limbs
* English Speaking
* Chronic phantom limb pain (at least 6-months duration)
* Average phantom limb pain intensity of 4 or greater on a 0-10 numerical rating scale
* Average frequency of phantom limb pain episode of at least twice per month.
* Residual limb pain of less than 5 on the Numerical Pain Rating Scale
* Pain medication use stable for \> 1 month

Exclusion Criteria

* Unable to tolerate use of liner or cuff on their residual limb
* Skin irritation/wounds on residual limb that would prevent use of the electrode cuff
* Significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback.
* Non-English speaking

Primary outcomes:
measure: Short-form McGill Pain Questionnaire
timeFrame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
measure: Patient-Reported Outcomes Measurement Information Systems (PROMIS)
timeFrame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Levi Hargrove, PhD
role: PRINCIPAL_INVESTIGATOR
References: