Chronic PainNAPSNCT02284542
NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators
An observational study of Chronic Pain and Sciatica, run by St. Luke's Hospital, Pennsylvania at 4 sites in United States.
Trial summary
The primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, non-randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Sciatica, Failed Back Surgery Syndrome
- What is being tested?
- Awake and Non-Awake
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2014to 31 Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.
Who may be able to join
- Patients who have had a successful spinal cord stimulation trial and are indicated for permanent implantation at a participating facility.
- Sign informed consent
Who cannot join
- < 18 years of age
Trial locations and contacts
4 sites in 1 country.
United States4 sites
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Geisinger Medical Center
Danville, Pennsylvania, 17822
Penn State Hershey Neurosciences Institute
Hershey, Pennsylvania, 17033
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: NAPS (Non-awake Versus Awake Placement of Spinal Cord Stimulators) Study for the Evaluation of Awake and Non-awake Methods of SCS Paddle Lead Placement
The primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will be implanted from up to 4 active sites, coordinated by a single lead investigator.
Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.
- Conditions
- Chronic Pain, Sciatica, Failed Back Surgery Syndrome
- Being tested
- Awake, Non-Awake
- Medical subject headings
- Chronic Pain, Sciatica, Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AwakeProcedure or surgery
Upon approximate lead positioning, the patient is brought to a conscious sedated state while maintaining local anesthetic. Stimulation of the spinal cord through the paddle lead is accomplished with an external pulse generator, while communicating with the patient regarding paresthesia coverage of painful regions.
Non-AwakeProcedure or surgery
The patient is maintained under general anesthesia for the full duration of the implant. Upon approximate lead positioning, bilateral EMG of myotomes overlapping dermatomal regions of pain are monitored. Stimulation is delivered through the lead by an external pulse generator in order to elicit compound muscle action potentials (CMAPs) in the target regions. Lead placement is targeted to have symmetric CMAPs (i.e. physiologic midline) and adequate coverage of the painful regions as described by Falowski et al.
(Falowski et al., 2011).
| Study group | Role | What they receive |
|---|---|---|
| Patients with successful trial implant | Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician. Receives: Procedure: Awake; Procedure: Non-Awake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by the number of adverse events
Measured: 24 weeks
Efficacy assessed by the procedure time and number of revision differences between the Awake and Non-Awake methods
Measured: 24 weeks
Secondary outcomes (3)
Pain Evaluation
Measured: 24 weeks
Pain Location
Measured: 24 weeks
Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study start1 Nov 2014
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Steven Falowski, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284542
- Sponsor's protocol ID
- 2014-81
- Acronym
- NAPS
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2014
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: SJM and Dr. Falowski will share results upon study completion.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAPS (Non-awake Versus Awake Placement of Spinal Cord Stimulators) Study for the Evaluation of Awake and Non-awake Methods of SCS Paddle Lead Placement
- ClinicalTrials.gov ID
- NCT02284542
- Acronym / sponsor ID
- NAPS / 2014-81
- Conditions
- Chronic Pain, Sciatica, Failed Back Surgery Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 1 Nov 2014
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 6 Nov 2014 (estimated)
- 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 primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will be implanted from up to 4 active sites, coordinated by a single lead investigator.
Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with successful trial implant | – | Procedure: Awake, Procedure: Non-AwakePatients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.
Key inclusion criteria (2 listed)
- Patients who have had a successful spinal cord stimulation trial and are indicated for permanent implantation at a participating facility.
- Sign informed consent
Key exclusion criteria (1 listed)
- < 18 years of age
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 |
|---|---|---|
| AwakeUpon approximate lead positioning, the patient is brought to a conscious sedated state while maintaining local anesthetic. Stimulation of the spinal cord through the paddle lead is accomplished with an external pulse generator, while communicating with the patient regarding paresthesia coverage of painful regions. | Procedure or surgery | Patients with successful trial implant |
| Non-AwakeThe patient is maintained under general anesthesia for the full duration of the implant. Upon approximate lead positioning, bilateral EMG of myotomes overlapping dermatomal regions of pain are monitored. Stimulation is delivered through the lead by an external pulse generator in order to elicit compound muscle action potentials (CMAPs) in the target regions. Lead placement is targeted to have symmetric CMAPs (i.e. physiologic midline) and adequate coverage of the painful regions as described by Falowski et al. (Falowski et al., 2011). | Procedure or surgery | Patients with successful trial implant |
Primary outcome
Safety assessed by the number of adverse events
Time frame: 24 weeks
Efficacy assessed by the procedure time and number of revision differences between the Awake and Non-Awake methods
Time frame: 24 weeks
3 secondary outcomes
Pain Evaluation
Time frame: 24 weeks
Pain Location
Time frame: 24 weeks
Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Yes. SJM and Dr. Falowski will share results upon study completion.
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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.
Steven Falowski, MD principal investigator
Principal Investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Sciatica, run by St. Luke's Hospital, Pennsylvania at 4 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety assessed by the number of adverse events (time frame: 24 weeks). 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 22 Oct 2021.