An observational study in Amputation and Sensation, Phantom, sponsored by Lee Fisher, PhD. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-10-15.
Sponsored by Lee Fisher, PhD · Observational
The goal of this project is to characterize the types of sensations that can be evoked via electrical stimulation of the spinal cord and spinal nerves. Patients will be recruited from a local pain clinic, each with a spinal cord stimulation device implanted, to participate in experiments to explore the ability to modulate and control the modality, intensity, focality, and location of the sensations evoked by stimulation through the spinal cord stimulator leads. Investigators will connect spinal cord stimulator leads to a custom stimulator system and will ask subjects to report the types of sensations felt. Invesigators will also perform detailed psychophysical metrics to examine participants' ability to discriminate sensations.
For this study, investigators aim to determine whether DRG and spinal root stimulation might be viable techniques for restoring feedback. Investigators will focus on patients undergoing temporary percutaneous trials of DRG or lateral spinal cord stimulation with leads manufactured by either Boston Scientific (under PMA P030017) or St. Jude (under PMA P150004), which have FDA premarket approval for the management of chronic pain in the trunk and lower limbs. In this early experiment, investigators will not focus on individuals with limb loss, but rather will include patients already undergoing a percutaneous trial of DRG or spinal root stimulation to treat pain. Investigators will characterize the location, modality, and intensity of sensations evoked in the hands or feet with stimulation delivered by an external stimulator.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
Browse Phantom Limb studies →Lee Fisher, PhD is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Individuals undergoing a 7-day trial period of percutaneous DRG or spinal root stimulation.
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Exclusion Criteria:
During psychophysical stimulation trials, an external stimulator will be connected to the SCS lead, a volley of stimulation will be performed, and the subject will be asked to respond to standard psychophysical questions, as well as to provide any additional comments.
Device: Spinal cord stimulation system
These systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain. Stimulation will be applied to the system using an external stimulator to see if sensations can be evoked in the participant's limb/foot.
Also known as: Boston Scientific, St. Jude
Location of evoked sensory percepts
Document where on the body the subject perceives the stimulation locations.
Time frame: up to 2 days
Stimulation perceptual thresholds to stimulus parameters
Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.
Time frame: up to 2 days
Stimulation neurophysiology thresholds to stimulus parameters
Quantify the threshold stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation
Time frame: up to 2 days
Qualitative self-report of evoked sensations
Document the subjective perception of lumbosacral 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.
Time frame: up to 2 days
Plan to share: No
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Ran from Dec 2020 to primary completion in Jul 2025, 54 months.
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This study is withdrawn, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Lee Fisher, PhD