Clinical trial NCT04725006: Sensory Responses to Dorsal Root Stimulation
Official title: Sensory Responses to Dorsal Root Stimulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amputation
Sensation, Phantom
Keywords: spinal cord stimulation
dorsal root ganglia stimulation
sensation
amputation
pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals undergoing a 7-day trial period of percutaneous DRG or spinal root stimulation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be between the ages of 18 and 70 years old.
2. Subjects must be undergoing an epidural spinal cord implanted electrode array clinical trial with Dr. Helm for the management of pain.
3. Persons must understand the consent and the procedures.

Exclusion Criteria:

1. Persons with open wounds;
2. Persons with implanted metal rods in the spine or limbs;
3. Persons with defibrillator or pacemaker;
4. Persons with permanent skin metal tags or decorations.

Primary outcomes:
measure: Location of evoked sensory percepts
timeFrame: up to 2 days
measure: Stimulation perceptual thresholds to stimulus parameters
timeFrame: up to 2 days
measure: Stimulation neurophysiology thresholds to stimulus parameters
timeFrame: up to 2 days
Secondary outcomes:
measure: Qualitative self-report of evoked sensations
timeFrame: up to 2 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Lee Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References: