Sensory Responses to Dorsal Root Stimulation

Not Applicable

Recruiting

• Conditions: Amputation; Sensation, Phantom

• Registration Number: NCT04725006
• Lead Sponsor: Lee Fisher, PhD

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.

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-29
• Study Start: 2025-10
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Location of evoked sensory percepts	up to 2 days	Document where on the body the subject perceives the stimulation locations.
Stimulation neurophysiology thresholds to stimulus parameters	up to 2 days	Quantify the threshold stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation
Stimulation perceptual thresholds to stimulus parameters	up to 2 days	Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.

Secondary Outcome Measures

Name	Time	Method
Qualitative self-report of evoked sensations	up to 2 days	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States