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Sensory Responses to Dorsal Root Stimulation

Studies

Study First Submitted Date 2021-01-21
Study First Posted Date 2021-01-26
Last Update Posted Date 2023-06-05
Start Month Year June 1, 2024
Primary Completion Month Year November 15, 2025
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-05

Detailed Descriptions

Sequence: 20693238
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.

Facilities

Sequence: 199749316
Status Recruiting
Name University of Pittsburgh
City Pittsburgh
State Pennsylvania
Zip 15213
Country United States

Facility Contacts

Sequence: 28071664 Sequence: 28071665
Facility Id 199749316 Facility Id 199749316
Contact Type primary Contact Type backup
Name Casey Konopisos Name Debbie Harrington
Email clk130@pitt.edu Email debbie.harrington@pitt.edu
Phone 412-642-4035 Phone 4123831355

Facility Investigators

Sequence: 18309021
Facility Id 199749316
Role Principal Investigator
Name Lee Fisher, PhD

Conditions

Sequence: 52094917 Sequence: 52094918
Name Amputation Name Sensation, Phantom
Downcase Name amputation Downcase Name sensation, phantom

Id Information

Sequence: 40098472
Id Source org_study_id
Id Value STUDY20020043

Countries

Sequence: 42500680
Name United States
Removed False

Design Groups

Sequence: 55510061
Group Type Experimental
Title Stimulation in individuals with implanted stimulation systems
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.

Interventions

Sequence: 52408601
Intervention Type Device
Name Spinal cord stimulation system
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.

Keywords

Sequence: 79744534 Sequence: 79744530 Sequence: 79744531 Sequence: 79744532 Sequence: 79744533
Name pain Name spinal cord stimulation Name dorsal root ganglia stimulation Name sensation Name amputation
Downcase Name pain Downcase Name spinal cord stimulation Downcase Name dorsal root ganglia stimulation Downcase Name sensation Downcase Name amputation

Design Outcomes

Sequence: 177117205 Sequence: 177117206 Sequence: 177117207 Sequence: 177117208
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary
Measure Location of evoked sensory percepts Measure Stimulation perceptual thresholds to stimulus parameters Measure Stimulation neurophysiology thresholds to stimulus parameters Measure Qualitative self-report of evoked sensations
Time Frame up to 2 days Time Frame up to 2 days Time Frame up to 2 days Time Frame up to 2 days
Description Document where on the body the subject perceives the stimulation locations. Description Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation. Description Quantify the threshold stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation 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.

Browse Conditions

Sequence: 193185610 Sequence: 193185611 Sequence: 193185612 Sequence: 193185613 Sequence: 193185614 Sequence: 193185615 Sequence: 193185616 Sequence: 193185617 Sequence: 193185618
Mesh Term Phantom Limb Mesh Term Perceptual Disorders Mesh Term Neurobehavioral Manifestations Mesh Term Neurologic Manifestations Mesh Term Nervous System Diseases Mesh Term Pain, Postoperative Mesh Term Postoperative Complications Mesh Term Pathologic Processes Mesh Term Pain
Downcase Mesh Term phantom limb Downcase Mesh Term perceptual disorders Downcase Mesh Term neurobehavioral manifestations Downcase Mesh Term neurologic manifestations Downcase Mesh Term nervous system diseases Downcase Mesh Term pain, postoperative Downcase Mesh Term postoperative complications Downcase Mesh Term pathologic processes Downcase Mesh Term pain
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48249064
Agency Class OTHER
Lead Or Collaborator lead
Name Lee Fisher, PhD

Overall Officials

Sequence: 29241391
Role Principal Investigator
Name Lee Fisher, PhD
Affiliation University of Pittsburgh

Central Contacts

Sequence: 11992760 Sequence: 11992761
Contact Type primary Contact Type backup
Name Casey Konopisos Name Debbie Harrington
Phone 4126484035 Phone 4123831355
Email clk130@pitt.edu Email debbie.harrington@pitt.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 68047763
Design Group Id 55510061
Intervention Id 52408601

Eligibilities

Sequence: 30721448
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253964389
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30467937
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26631045 Sequence: 26631046
Intervention Id 52408601 Intervention Id 52408601
Name Boston Scientific Name St. Jude

Responsible Parties

Sequence: 28834383
Responsible Party Type Sponsor-Investigator
Name Lee Fisher, PhD
Title Assistant Professor
Affiliation University of Pittsburgh