Chronic PainNCT05459324
Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II
A study testing HD Study Electrode in people with Chronic Pain and Neuropathic Pain, run by Albany Medical College at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Pain, Neuropathic Pain, Failed Back Surgery Syndrome
- What is being tested?
- HD Study Electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 31 Dec 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing a spinal cord stimulation procedure for neuropathic pain.
- have undergone a successful SCS trial and are determined eligible for a permanent SCS implant.
- Patients must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.-
- subjects must be able to give informed consent.
Who cannot join
- patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording: Phase II
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
- Conditions
- Chronic Pain, Neuropathic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes
- Being tested
- HD Study Electrode
- Keywords
- Spinal cord stimulation, chronic pain
- Medical subject headings
- Chronic Pain, Neuralgia, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD Study ElectrodeDevice
The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Twenty-four patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care Receives: Device: HD Study Electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.
Measured: 3 months
Secondary outcomes (4)
McGill Pain Questionnaire (MPQ)
Patients select words that describe their pain. There are a total of 15 words. A higher score (more words selected) indicates worse outcome with a range from 0-15.
Measured: 3 month
Oswestry Disability Index (ODI)
This is a multiple choice style scale where patients are presented with an activity and asked to select a description which best matches their ability to perform that activity. Multiple choice options are then scored on a scale from 0-5; where 0 is no issues performing the activity and 5 is cannot perform activity. A higher score indicates worse outcome. The range in scores is from 0-100.
Measured: 3 months
Pain Catastrophizing Scale (PCS)
Patients are presented with a series of statements and they are asked to rate on a scale from 0-4, how often these statements apply to them when they are in pain. 0= never and 4= always. A higher score indicates worse outcome. Scores range from 0-52.
Measured: 3 months
Beck Depression Index (BDI)
This is a multiple choice style scale where patients are asked to select a statement related to a feeling of sadness or a component of depression. Multiple choice options are then scored on a scale from 0-3; where 0 is they do not feel that way and 3 is they do feel that way. A higher score indicates worse outcome. Scores range from 0-63
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start8 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Statistics will be performed comparing the HR-SCS to commercial SCS devices. Additionally, we will correlate patient reported outcomes and spinal measurements to IONM outcomes to determine overall device capabilities.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459324
- Sponsor's protocol ID
- 6426 Microleads
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Berwal D, Quintero A, Telkes I, DiMarzio M, Harland T, Paniccioli S, Dalfino J, Iyassu Y, McLaughlin BL, Pilitsis JG. Improved Selectivity in Eliciting Evoked Electromyography Responses With High-Resolution Spinal Cord Stimulation. Neurosurgery. 2024 Aug 1;95(2):322-329. doi: 10.1227/neu.0000000000002878. Epub 2024 Feb 20.
PubMed 38376181
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording: Phase II
- ClinicalTrials.gov ID
- NCT05459324
- Acronym / sponsor ID
- 6426 Microleads
- Conditions
- Chronic Pain, Neuropathic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes
- Keywords
- Spinal cord stimulation, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Jul 2022 (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 demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Statistics will be performed comparing the HR-SCS to commercial SCS devices. Additionally, we will correlate patient reported outcomes and spinal measurements to IONM outcomes to determine overall device capabilities.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: HD Study ElectrodeTwenty-four patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing a spinal cord stimulation procedure for neuropathic pain.
- have undergone a successful SCS trial and are determined eligible for a permanent SCS implant.
- Patients must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.-
- subjects must be able to give informed consent.
Key exclusion criteria (1 listed)
- patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain
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 |
|---|---|---|
| HD Study ElectrodeThe HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns. | Device | Study Group |
Primary outcome
Numeric Rating Scale
Time frame: 3 months
Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.
4 secondary outcomes
McGill Pain Questionnaire (MPQ)
Time frame: 3 month
Oswestry Disability Index (ODI)
Time frame: 3 months
Pain Catastrophizing Scale (PCS)
Time frame: 3 months
Beck Depression Index (BDI)
Time frame: 3 months
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 16 Jul 2024.
- Derived from this study: PubMed 38376181Berwal D, Quintero A, Telkes I, DiMarzio M, Harland T, Paniccioli S, Dalfino J, Iyassu Y, McLaughlin BL, Pilitsis JG. Improved Selectivity in Eliciting Evoked Electromyography Responses With High-Resolution Spinal Cord Stimulation. Neurosurgery. 2024 Aug 1;95(2):322-329. doi: 10.1227/neu.0000000000002878. Epub 2024 Feb 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD Study Electrode in people with Chronic Pain and Neuropathic Pain, run by Albany Medical College 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 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 16 Jul 2024. 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 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?
Numeric Rating Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459324, which also lists 1 linked publication.
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 16 Jul 2024.