Pain ManagementNCT07095036
Sensory Spinal Cord Stimulation
A study testing Spinal cord stimulation (SCS) in people with Pain Management and Pain, Intractable, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain Management, Pain, Intractable, Pain, Chronic Disease
- What is being tested?
- Spinal cord stimulation (SCS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects with high risk of falling
- Refusal to participate in study
- Subjects lacking consent capacity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ambulatory Care Center
Chapel Hill, North Carolina, 27514
Jacob Slack, 269-362-4203, jcslack@email.unc.edu
About this study
Official title: Generating Artificial Sensory Perceptions Using Spinal Cord Stimulation
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.
- Conditions
- Pain Management, Pain, Intractable, Pain, Chronic Disease
- Being tested
- Spinal cord stimulation (SCS)
- Medical subject headings
- Agnosia, Pain, Intractable, Pain, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulation (SCS)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.
| Study group | Role | What they receive |
|---|---|---|
| Assessing sensations using spinal cord stimulation | Experimental | Not described Receives: Other: Spinal cord stimulation (SCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold amplitude for sensory perception evoked by spinal stimulation
The outcome measure will determine the threshold stimulation amplitude in microamperes required to evoke a perceivable sensory percept during spinal stimulation.
Measured: From lead implantation to lead explantation at one week
Change in amplitude to perceive a just-noticeable difference in sensory perception evoked by spinal stimulation
The outcome measure will determine the minimum change in stimulation amplitude in microamperes required to evoke a perceivable difference in sensory percepts during spinal stimulation.
Measured: From lead implantation to lead explantation at one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start6 Jan 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Amol Yadav, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095036
- Sponsor's protocol ID
- 24-0213
- Other IDs
- 7DP2NS136872-02
- Status last verified
- Dec 2025
- First submitted
- 16 Jun 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generating Artificial Sensory Perceptions Using Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT07095036
- Acronym / sponsor ID
- 24-0213
- Conditions
- Pain Management, Pain, Intractable, Pain, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessing sensations using spinal cord stimulation | Experimental | Other: Spinal cord stimulation (SCS) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Subjects with high risk of falling
- Refusal to participate in study
- Subjects lacking consent capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Assessing sensations using spinal cord stimulation |
Primary outcome
Threshold amplitude for sensory perception evoked by spinal stimulation
Time frame: From lead implantation to lead explantation at one week
The outcome measure will determine the threshold stimulation amplitude in microamperes required to evoke a perceivable sensory percept during spinal stimulation.
Change in amplitude to perceive a just-noticeable difference in sensory perception evoked by spinal stimulation
Time frame: From lead implantation to lead explantation at one week
The outcome measure will determine the minimum change in stimulation amplitude in microamperes required to evoke a perceivable difference in sensory percepts during spinal stimulation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amol Yadav, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation (SCS) in people with Pain Management and Pain, Intractable, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threshold amplitude for sensory perception evoked by spinal stimulation (time frame: From lead implantation to lead explantation at one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.