Sensory Responses to Dorsal Root Stimulation

NCT04725006 | Withdrawn FDA Device

• 1 other identifier: STUDY20020043
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Sensation, Phantom

Keywords

spinal cord stimulation; dorsal root ganglia stimulation; sensation; amputation; pain

Outcome Measures

Primary Outcomes (3)

• Location of evoked sensory percepts

  Document where on the body the subject perceives the stimulation locations.

  up to 2 days

• Stimulation perceptual thresholds to stimulus parameters

  Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.

  up to 2 days

• Stimulation neurophysiology thresholds to stimulus parameters

  Quantify the threshold stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation

  up to 2 days

Secondary Outcomes (1)

• Qualitative self-report of evoked sensations

  up to 2 days

Study Arms (1)

Stimulation in individuals with implanted stimulation systems

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

Interventions

Spinal cord stimulation system DEVICE

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

Stimulation in individuals with implanted stimulation systems

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals undergoing a 7-day trial period of percutaneous DRG or spinal root stimulation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lee Fisher, PhD: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Phantom Limb; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Lee Fisher, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: December 16, 2020
• Primary Completion: July 11, 2025
• Study Completion: October 7, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)