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Sensory Responses to Dorsal Root Stimulation

Primary Purpose

Amputation, Sensation, Phantom

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal cord stimulation system
Sponsored by
Lee Fisher, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Amputation focused on measuring spinal cord stimulation, dorsal root ganglia stimulation, sensation, amputation, pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stimulation in individuals with implanted stimulation systems

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 21, 2021
Last Updated
June 2, 2023
Sponsor
Lee Fisher, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT04725006
Brief Title
Sensory Responses to Dorsal Root Stimulation
Official Title
Sensory Responses to Dorsal Root Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
November 15, 2025 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lee Fisher, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Sensation, Phantom
Keywords
spinal cord stimulation, dorsal root ganglia stimulation, sensation, amputation, pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation in individuals with implanted stimulation systems
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation system
Other Intervention Name(s)
Boston Scientific, St. Jude
Intervention Description
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.
Primary Outcome Measure Information:
Title
Location of evoked sensory percepts
Description
Document where on the body the subject perceives the stimulation locations.
Time Frame
up to 2 days
Title
Stimulation perceptual thresholds to stimulus parameters
Description
Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.
Time Frame
up to 2 days
Title
Stimulation neurophysiology thresholds to stimulus parameters
Description
Quantify the threshold stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation
Time Frame
up to 2 days
Secondary Outcome Measure Information:
Title
Qualitative self-report of evoked sensations
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casey Konopisos
Phone
4126484035
Email
clk130@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debbie Harrington
Phone
4123831355
Email
debbie.harrington@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Fisher, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey Konopisos
Phone
412-642-4035
Email
clk130@pitt.edu
First Name & Middle Initial & Last Name & Degree
Debbie Harrington
Phone
4123831355
Email
debbie.harrington@pitt.edu
First Name & Middle Initial & Last Name & Degree
Lee Fisher, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Sensory Responses to Dorsal Root Stimulation

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