Back Pain With RadiationNCT02614079
Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing
A study testing DSSEP in people with Back Pain With Radiation, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction achieved correlates with the degree of stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain With Radiation
- What is being tested?
- DSSEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2016to 9 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- A subject will be eligible for inclusion in this study only if all the following criteria apply:
- Subject understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities.
- Subjects are male or female greater than 18 years old at the time of screening visit.
- Pain in one or both lower extremities. D. Pain is not responding to conservative treatment such as physical therapy or medications.
- Average pain rating of at least 4 on a scale 0 to 10, on average, prior to enrollment in the study.
- Patient is mentally competent to make decisions.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Female subject with childbearing potential (a premenopausal female, who is not surgically sterile).
- Subjects who poorly cooperate or have any cognitive impairment. C. Patient with severe concomitant depression. D. Inability to communicate adequately with physician and /or study coordinator.
- Patient is diagnosed with a psychiatric condition that will likely interfere with diagnostic accuracy of the workup protocol or with recovery following the anticipated procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Percutaneous Spinal Cord Stimulation Trial Using the Dermatomal Somatosensory Evoked Potentials (DSSEP) Collision Testing
This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction achieved correlates with the degree of stimulation.
Read the detailed description
The SCS trial leads will be placed as per standard of care, using fluoroscopic guidance and leads will be checked for proper positioning. Leads will be tested for appropriate paresthesia coverage of the patient's painful area(s), using multiple electrode configurations and lead positions (dependent on the location of the pain). After the leads are secured, the patient will be sent to the recovery room where the DSSEP test will be performed. A technologist will glue/tape recording electrodes to the patient's head, neck, back or legs. One or two stimulating electrodes are also placed on the patient's leg. Each electrode is checked with a meter to ensure proper functioning. Pulsing stimulus will start in one of the stimulating electrodes. Each time a different area is tested, the pulsing will be started again. Each area tested will take 10-15 minutes. The painful dermatomal distribution area, specific to each patient will be used for dermatomal SSEP stimulation. Placement will be correlated with nerve roots involved with the corresponding dermatomes. Measurements will be obtained to determine collision criteria.
- Conditions
- Back Pain With Radiation
- Being tested
- DSSEP
- Keywords
- lumbago, low back pain, leg pain
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSSEPDevice
Collision testing after the placement of SCS leads
| Study group | Role | What they receive |
|---|---|---|
| DSSEP | Experimental | DSSEP testing after SCS trial lead placement Receives: Device: DSSEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Positive Collision
Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start20 Jan 2016
- Primary completion7 Dec 2016
- Study completion9 Nov 2017
Why it stopped: Lack of enrollment. Futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back Pain With RadiationStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph N Atallah, MD, Principal investigator, Universtiy of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614079
- Sponsor's protocol ID
- Atallah SCS DSSEP
- Status last verified
- Jan 2018
- First submitted
- 23 Nov 2015
- Last updated
- 15 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study was terminated early due to lack of enrollment.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Percutaneous Spinal Cord Stimulation Trial Using the Dermatomal Somatosensory Evoked Potentials (DSSEP) Collision Testing
- ClinicalTrials.gov ID
- NCT02614079
- Acronym / sponsor ID
- Atallah SCS DSSEP
- Conditions
- Back Pain With Radiation
- Keywords
- lumbago, low back pain, leg pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment. Futility.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction achieved correlates with the degree of stimulation.
Detailed description
The SCS trial leads will be placed as per standard of care, using fluoroscopic guidance and leads will be checked for proper positioning. Leads will be tested for appropriate paresthesia coverage of the patient's painful area(s), using multiple electrode configurations and lead positions (dependent on the location of the pain). After the leads are secured, the patient will be sent to the recovery room where the DSSEP test will be performed. A technologist will glue/tape recording electrodes to the patient's head, neck, back or legs. One or two stimulating electrodes are also placed on the patient's leg. Each electrode is checked with a meter to ensure proper functioning. Pulsing stimulus will start in one of the stimulating electrodes. Each time a different area is tested, the pulsing will be started again. Each area tested will take 10-15 minutes. The painful dermatomal distribution area, specific to each patient will be used for dermatomal SSEP stimulation. Placement will be correlated with nerve roots involved with the corresponding dermatomes. Measurements will be obtained to determine collision criteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSSEP | Experimental | Device: DSSEPDSSEP testing after SCS trial lead placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A subject will be eligible for inclusion in this study only if all the following criteria apply:
- Subject understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities.
- Subjects are male or female greater than 18 years old at the time of screening visit.
- Pain in one or both lower extremities. D. Pain is not responding to conservative treatment such as physical therapy or medications.
- Average pain rating of at least 4 on a scale 0 to 10, on average, prior to enrollment in the study.
Key exclusion criteria (4 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Female subject with childbearing potential (a premenopausal female, who is not surgically sterile).
- Subjects who poorly cooperate or have any cognitive impairment. C. Patient with severe concomitant depression. D. Inability to communicate adequately with physician and /or study coordinator.
- Patient is diagnosed with a psychiatric condition that will likely interfere with diagnostic accuracy of the workup protocol or with recovery following the anticipated procedure
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 |
|---|---|---|
| DSSEPCollision testing after the placement of SCS leads | Device | DSSEP |
Primary outcome
Number of Participants With Positive Collision
Time frame: Day 1
Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The study was terminated early due to lack of enrollment.
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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.
Joseph N Atallah, MD principal investigator
Universtiy of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSSEP in people with Back Pain With Radiation, run by University of Toledo Health Science Campus 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 6 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: stopped early, as of the sponsor's last update on 15 Mar 2018. 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?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Positive Collision (time frame: Day 1). 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 Mar 2018.