AmputationNCT04725006
Sensory Responses to Dorsal Root Stimulation
An observational study of Amputation and Sensation, Phantom, run by Lee Fisher, PhD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amputation, Sensation, Phantom
- What is being tested?
- Spinal cord stimulation system
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2020to 7 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals undergoing a 7-day trial period of percutaneous DRG or spinal root stimulation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Amputation, Sensation, Phantom
- Being tested
- Spinal cord stimulation system
- Keywords
- spinal cord stimulation, dorsal root ganglia stimulation, sensation, amputation, pain
- Medical subject headings
- Phantom Limb, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulation systemDevice
Also called Boston Scientific, St. Jude
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spinal cord stimulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Location of evoked sensory percepts
Document where on the body the subject perceives the stimulation locations.
Measured: up to 2 days
Stimulation perceptual thresholds to stimulus parameters
Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.
Measured: up to 2 days
Stimulation neurophysiology thresholds to stimulus parameters
Quantify the threshold stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation
Measured: up to 2 days
Secondary outcomes (1)
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.
Measured: up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start16 Dec 2020
- Primary completion11 Jul 2025
- Study completion7 Oct 2025
Why it stopped: No participant/patient opportunities for testing. Received funding for a different study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee Fisher, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lee Fisher, PhD, University of Pittsburgh
- Investigators
- Lee Fisher, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725006
- Sponsor's protocol ID
- STUDY20020043
- Status last verified
- Oct 2025
- First submitted
- 21 Jan 2021
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Responses to Dorsal Root Stimulation
- ClinicalTrials.gov ID
- NCT04725006
- Acronym / sponsor ID
- STUDY20020043
- Conditions
- Amputation, Sensation, Phantom
- Keywords
- spinal cord stimulation, dorsal root ganglia stimulation, sensation, amputation, pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participant/patient opportunities for testing. Received funding for a different study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lee Fisher, PhDUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 26 Jan 2021 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation in individuals with implanted stimulation systems | – | Device: Spinal cord stimulation systemDuring 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals undergoing a 7-day trial period of percutaneous DRG or spinal root stimulation.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 systemAlso: Boston Scientific, St. JudeThese 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. | Device | Stimulation in individuals with implanted stimulation systems |
Primary outcome
Location of evoked sensory percepts
Time frame: up to 2 days
Document where on the body the subject perceives the stimulation locations.
Stimulation perceptual thresholds to stimulus parameters
Time frame: up to 2 days
Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.
Stimulation neurophysiology thresholds to stimulus parameters
Time frame: up to 2 days
Quantify the threshold stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation
1 secondary outcome
Qualitative self-report of evoked sensations
Time frame: up to 2 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Amputation
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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. This study is not recruiting at the moment.
Lee Fisher, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Sensation, Phantom, run by Lee Fisher, PhD 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Oct 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location of evoked sensory percepts (time frame: up to 2 days). The study lists 3 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 15 Oct 2025.