Neuropathic PainECAPS SCSNCT03976219
Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion
A study testing ECAPS Closed Loop SCS in people with Neuropathic Pain, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- ECAPS Closed Loop SCS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2019to 9 Dec 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age.
- Subject is able and willing to comply with the schedule and protocol.
- For implantation of DRG stimulator;
- Subject has been diagnosed with complex regional pain syndrome (CRPS I or II).
- Subject has had chronic, intractable pain of the groin or lower limbs for at least 6 months.
- Subject is indicated for implantation of an Abbott DRG stimulation system.
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- Subject will be undergoing trial implantation of an Abbott DRG stimulation system.
- For implantation of SCS;
- Subject has been diagnosed with chronic, intractable pain of the trunk and/or limbs.
- Subject is indicated for implantation of a SCS system.
- Subject will be undergoing implantation of an Abbott lead.
- Subject has had stable neurologic function in the past 30 days.
- Subject is able to provide informed consent.
Who cannot join
- Subject will be implanted with 3 or more DRG leads.
- Subject is currently participating in a clinical investigation that includes an active treatment arm.
- Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by physician examination.
- Subject currently has an active implantable device including an ICD, pacemaker, spinal cord stimulator, or intrathecal drug pump.
- Subject is a prisoner.
- Female subject is pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals.
- Conditions
- Neuropathic Pain
- Being tested
- ECAPS Closed Loop SCS
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECAPS Closed Loop SCSOther
The purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals.
| Study group | Role | What they receive |
|---|---|---|
| Evoked potentials of ECAPs and SSEPs | Experimental | Patients implanted with a spinal cord stimulator. In this arm, we are measuring the evoked potentials of electric compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs). Receives: Other: ECAPS Closed Loop SCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level as measured by pain scale
Measured on a scale 0 to 10, with 0 being no pain and 10 being pain as bad as you can imagine.
Measured: Visit 1, up to 2 hours
Evoked response amplitude for ECAPS
Evoked responses averaged across trials for ECAPS, measured in micro Volts
Measured: Visit 1, up to 2 hours
Evoked response amplitude for SSEPs
Evoked responses averaged across trials for SSEPs, measured in micro Volts
Measured: Visit 1, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start13 Jun 2019
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Why it stopped: Budgetary Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Viventi, PhD, Principal investigator, Duke UniversityNandan Lad, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976219
- Sponsor's protocol ID
- Pro00100055
- Acronym
- ECAPS SCS
- Status last verified
- Jul 2023
- First submitted
- 4 Jun 2019
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion
- ClinicalTrials.gov ID
- NCT03976219
- Acronym / sponsor ID
- ECAPS SCS / Pro00100055
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Budgetary Issues
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 5 Jun 2019 (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 study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evoked potentials of ECAPs and SSEPs | Experimental | Other: ECAPS Closed Loop SCSPatients implanted with a spinal cord stimulator. In this arm, we are measuring the evoked potentials of electric compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is at least 18 years of age.
- Subject is able and willing to comply with the schedule and protocol.
- For implantation of DRG stimulator;
- Subject has been diagnosed with complex regional pain syndrome (CRPS I or II).
- Subject has had chronic, intractable pain of the groin or lower limbs for at least 6 months.
Key exclusion criteria (6 listed)
- Subject will be implanted with 3 or more DRG leads.
- Subject is currently participating in a clinical investigation that includes an active treatment arm.
- Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by physician examination.
- Subject currently has an active implantable device including an ICD, pacemaker, spinal cord stimulator, or intrathecal drug pump.
- Subject is a prisoner.
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 |
|---|---|---|
| ECAPS Closed Loop SCSThe purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals. | Other | Evoked potentials of ECAPs and SSEPs |
Primary outcome
Pain level as measured by pain scale
Time frame: Visit 1, up to 2 hours
Measured on a scale 0 to 10, with 0 being no pain and 10 being pain as bad as you can imagine.
Evoked response amplitude for ECAPS
Time frame: Visit 1, up to 2 hours
Evoked responses averaged across trials for ECAPS, measured in micro Volts
Evoked response amplitude for SSEPs
Time frame: Visit 1, up to 2 hours
Evoked responses averaged across trials for SSEPs, measured in micro Volts
Results and safety
The study was stopped early (reason given: Budgetary Issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Jonathan Viventi, PhD principal investigator
Duke University
Nandan Lad, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECAPS Closed Loop SCS in people with Neuropathic Pain, run by Duke University 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 13 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Jul 2023. 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 stopped early (reason given: Budgetary Issues). Results are not available in the source record.
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?
Pain level as measured by pain scale (time frame: Visit 1, up to 2 hours). 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 10 Jul 2023.