Phantom Limb Clinical Trial
— PhantomLimbOfficial title:
Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees
Individuals with upper-limb amputation usually have intact nerves within the residual limb, and studies have demonstrated that electrical stimulation of those nerves can produce sensations that appear to emanate from the amputated limb. In this study, investigators will examine the sensations that are produced by electrical stimulation of these nerves at the location where they exit the spinal cord. Stimulation of the spinal cord is commonly used to treat intractable back and limb pain, and the procedure includes a test phase in which electrodes are temporarily placed under the skin near the spinal cord and removed at the end of testing. Similarly, in this study, electrodes will be placed near the spinal cord in the upper back and neck, and stimulation will be applied over the course of multiple testing sessions, lasting less than 30 days. The electrodes will be removed at the last day of testing. During each testing session, electrical stimulation will be applied through the electrodes and a series of tests will be performed to determine the types of sensations produced by stimulation. In addition to producing meaningful sensations with electrical stimulation, this study will also test the effect of stimulation on phantom limb sensations and phantom limb pain.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2026 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - have an upper-limb amputation - must be between the ages of 18 and 70 - be at least one year post-amputation - be willing to travel to the University of Pittsburgh at least twice per week for 29 days Exclusion Criteria: - women who are pregnant or plan to become pregnant during the study - all participants cannot have any serious diseases or disorders that affect your ability to participate in this study - must not be currently taking any medications that thin your blood |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Lee Fisher, PhD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stimulation thresholds to a variety of stimulus parameters | Quantify the threshold (minimum charge and pulse rate) stimulus required to evoke sensory percepts and neurophysiological responses (e.g. reflexive EMG responses, somatosensory evoked potentials) during epidural spinal nerve stimulation, and monitor changes in those percepts and responses over time. | 30 days | |
Secondary | Location and modality of evoked sensory percepts | Evaluate the relationship between stimulation parameters (e.g. pulse width, pulse amplitude, stimulus location, etc) and the modality and naturalness of perceived sensations. | 30 days | |
Secondary | Qualitative self-report of evoked sensations | Document the subjective perception of cervical epidural spinal nerve stimulation for restoration of sensation. The investigators will ask each subject to provide subjective feedback on their perceived utility of the sensory feedback provided by the device. | 30 days | |
Secondary | Change in pain ratings after study completion | Document changes in phantom limb sensation and phantom limb pain during and shortly after cervical epidural spinal nerve stimulation in amputees. Before placement of the spinal cord stimulator leads, investigators will document the subject's description of their history of perceived phantom limb. If subjects report a history of phantom limb pain, investigators will ask them to periodically update their perception of the limb throughout each experimental session, as well as within a month after the device has been removed. | 30 days | |
Secondary | Success rate during control of prosthetic hand | Investigators will test the subject's ability to use a myoelectric prosthetic hand with and without sensory feedback provided by electrical stimulation of the spinal roots. Using either a virtual prosthetic limb or an instrumented prosthesis, stimulation of the spinal roots will be modulated based on signals recorded from the limb such as pressure at the finger tips or joint angles. In both the presence and absence of stimulation, subjects will be asked to perform tasks such as manipulating blocks, opening a jar, or identifying the stiffness and size of various objects. | 30 days |
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