Sensory Spinal Cord Stimulation

NCT ID: NCT07095036

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-06

Study Completion Date

2028-09-01

Brief Summary

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The purpose of this research study is to identify sensations that can be evoked with spinal cord stimulation (SCS) and to understand how these sensations change when stimulation parameters are modified.

Detailed Description

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Conditions

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Pain Management Pain, Intractable Pain, Chronic Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Assessing sensations using spinal cord stimulation

Group Type EXPERIMENTAL

Spinal cord stimulation (SCS)

Intervention Type OTHER

After implantation of SCS trial leads - which is standard of care for evaluating whether SCS improves chronic pain - patients will visit clinic before the trial leads are explanted. During these visits, stimulation will be turned off and the leads will be disconnected from the clinical external pulse generator and reconnected to an external research stimulator. Patients will be seated in a chair and will interface with a touch-screen display where they will participate in a psychophysical task (a two-alternative forced-choice task). More specifically, the task will involve selecting between two options on a screen while spinal stimulation is delivered through the leads. As the patients perform the tasks, audio or video recordings will be made for future research analysis, education, or scientific communication. The research stimulator will also collect epidural signals through the stimulation leads.

Interventions

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Spinal cord stimulation (SCS)

After implantation of SCS trial leads - which is standard of care for evaluating whether SCS improves chronic pain - patients will visit clinic before the trial leads are explanted. During these visits, stimulation will be turned off and the leads will be disconnected from the clinical external pulse generator and reconnected to an external research stimulator. Patients will be seated in a chair and will interface with a touch-screen display where they will participate in a psychophysical task (a two-alternative forced-choice task). More specifically, the task will involve selecting between two options on a screen while spinal stimulation is delivered through the leads. As the patients perform the tasks, audio or video recordings will be made for future research analysis, education, or scientific communication. The research stimulator will also collect epidural signals through the stimulation leads.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male and female patients 18-85 years old
* Undergoing SCS implantation for treatment of chronic pain
* Subjects with ability to walk 10m without assistance
* Provides written consent for the study

Exclusion Criteria

* Subjects with high risk of falling
* Refusal to participate in study
* Subjects lacking consent capacity
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amol Yadav, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Ambulatory Care Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Jacob Slack

Role: primary

269-362-4203

Other Identifiers

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7DP2NS136872-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-0213

Identifier Type: -

Identifier Source: org_study_id

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