Chronic PainPhase 1LIFENCT06206356
Lumbar Injectrode Feasibility Evaluation
A Phase 1 study testing PNS Injectrode F1 in people with Chronic Pain and Lower Back Pain Chronic, run by Neuronoff, Inc at 1 site in United States.
Trial summary
The goal of this non-significant risk study is to determine whether stimulation with transcutaneous waveforms applied on the outside of the body and subcutaneously conducted to the lumbar medial branch nerve elicits visible (via ultrasonic imaging) or palpable multifidus muscle activation within the short-term (<28… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Lower Back Pain Chronic
- What is being tested?
- PNS Injectrode F1
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 15 Mar 2024
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 21 years of age or older when written informed consent is obtained.
- Literate, able to speak English and able to complete questionnaires independently.
- Willing to sign an Institutional Review Board (IRB)-approved informed consent form (ICF) and deemed capable of complying with the study requirements.
- Are currently receiving optimal medical management and considered medically stable as judged by the investigator for any significant medical condition.
- Be able to tolerate minimally invasive electrical stimulation.
- Be willing and able to understand and comply with all study-related procedures during the course of the study, and attend all scheduled study visits.
Who cannot join
- Severe cognitive impairment as determined by the Investigator.
- If female and sexually active, and the subject is not using a reliable form of birth control, is not surgically sterile or at least two years post-menopausal, the subject shall be excluded, as confirmed by the Investigator.
- If female, have a positive pregnancy test at the screening and/or Day 0 visit.
- Pre-existing motor, balance, proprioception, or sensory deficits as determined by Investigator.
- Show symptoms indicative of Covid-19 as assessed during enrollment.
- Have a skin condition at the planned surgical location.
Show all 21Show fewer
- Have a blood coagulation disorder or other indication with the potential to impact the study biocompatibility data in unpredictable ways.
- Have a medical condition that is a contraindication for minimally invasive procedures.
- Have a cardiac demand pacemaker, implanted defibrillator or another implanted electronic device.
- Have a history of cardiac arrhythmia with hemodynamic instability.
- Be implanted with a neurostimulator.
- Have any active electrical implant of any other kind.
- Have an active infection.
- Current coagulopathy, thrombocytopenia or bleeding diathesis (confirmed by clinical history and, if clinically indicated, by coagulation screening).
- Have untreated drug habituation or dependence.
- Have uncontrolled seizures (averaging > 2 seizures per month).
- Currently require, or be likely to require, diathermy and/or MRI during study duration.
- Known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject.
- Have a history of adverse reactions to local anesthetics (e.g. lidocaine).
- A systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, uncontrolled diabetes, etc.).
- Any experimental drug or device used within 30 days prior to the screening visit or during the course of the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this non-significant risk study is to determine whether stimulation with transcutaneous waveforms applied on the outside of the body and subcutaneously conducted to the lumbar medial branch nerve elicits visible (via ultrasonic imaging) or palpable multifidus muscle activation within the short-term (<28 day) placement of the Neuronoff PNS Injectrode F1 in healthy volunteers.
The main questions it aims to answer are:
Read more
- Can the PNS Injectrode F1 be safely inserted on the lumbar medial branch nerve for up to 28 days?
- Can the PNS Injectrode F1 be safely used to stimulate the lumbar medial branch nerve to activate the multifidus muscle?
Participants will
- Receive transcutaneous stimulation of the lower back prior to device placement, after device placement, and prior to explant
- Insert the PNS Injectrode F1 device on the lumbar medial branch nerve
- Have the device inserted for up to 28 days and then explanted
- Visit Schedule: Screening/Enrollment, Day 0, Day 2 (email), Day 25, 2 Days Post Explant (email), Day 35
- Conditions
- Chronic Pain, Lower Back Pain Chronic
- Being tested
- PNS Injectrode F1
- Keywords
- Neuromodulation, Injectable Electrode, Medical Device Safety, Injectrode, Healthy Volunteer
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNS Injectrode F1Device
Also called Injectrode
The PNS Injectrode F1 is a flexible conductor that conforms to the shape of a peripheral nerve and patient anatomy. The device is approximately 1 mm in overall diameter and is provided in lengths of 9 or 10 cm. The device is placed in a minimally invasive procedure via a standard 18g needle. The stimulating end of the device is placed in close proximity to the lumbar medial branch nerve with a collector end left subcutaneously. Electrical stimulation is provided via an externally placed patch electrode connected to the provided external pulse generator over the collector end of the device. Transcutaneous electrical stimulation will occur prior to device placement, on Day 0 after device placement, and on Day 25 prior to device removal. Minimally invasive removal is completed by a small incision and forceps using standard medical procedures and equipment.
| Study group | Role | What they receive |
|---|---|---|
| PNS Injectrode F1 | Experimental | Not described Receives: Device: PNS Injectrode F1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Device Effects (SADEs)
The safety endpoint will be the percentage of subjects that experience serious adverse device effects (SADE).
Measured: 35 days
Proportion of Subjects with Multifidus Muscle Activation as determined by PI via Ultrasound Imaging and Palpation
The efficacy endpoint will be the proportion of subjects with a clinically meaningful activation of the multifidus muscle(s) unilaterally or bilaterally utilizing transcutaneous stimulation on Day 0 and on or before the Day 25 visit. Meaningful activation will be evaluated by the PI based on ultrasonic imaging as well as palpation.
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start12 Jan 2024
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronoff, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio Pain Clinic
- Responsible party
- Sponsor
- Investigators
- Amol Soin, MD, MBA, Principal investigator, The Ohio Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206356
- Sponsor's protocol ID
- NCP-11
- Acronym
- LIFE
- Status last verified
- Apr 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Apr 2024
- 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Injectrode Feasibility Evaluation
- ClinicalTrials.gov ID
- NCT06206356
- Acronym / sponsor ID
- LIFE / NCP-11
- Conditions
- Chronic Pain, Lower Back Pain Chronic
- Keywords
- Neuromodulation, Injectable Electrode, Medical Device Safety, Injectrode, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Neuronoff, IncIndustry (pharma, biotech, devices)
- Collaborators
- Ohio Pain Clinic
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 16 Jan 2024 (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 non-significant risk study is to determine whether stimulation with transcutaneous waveforms applied on the outside of the body and subcutaneously conducted to the lumbar medial branch nerve elicits visible (via ultrasonic imaging) or palpable multifidus muscle activation within the short-term (<28 day) placement of the Neuronoff PNS Injectrode F1 in healthy volunteers.
The main questions it aims to answer are:
- Can the PNS Injectrode F1 be safely inserted on the lumbar medial branch nerve for up to 28 days?
- Can the PNS Injectrode F1 be safely used to stimulate the lumbar medial branch nerve to activate the multifidus muscle?
Participants will
- Receive transcutaneous stimulation of the lower back prior to device placement, after device placement, and prior to explant
- Insert the PNS Injectrode F1 device on the lumbar medial branch nerve
- Have the device inserted for up to 28 days and then explanted
- Visit Schedule: Screening/Enrollment, Day 0, Day 2 (email), Day 25, 2 Days Post Explant (email), Day 35
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PNS Injectrode F1 | Experimental | Device: PNS Injectrode F1 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 21 years of age or older when written informed consent is obtained.
- Literate, able to speak English and able to complete questionnaires independently.
- Willing to sign an Institutional Review Board (IRB)-approved informed consent form (ICF) and deemed capable of complying with the study requirements.
- Are currently receiving optimal medical management and considered medically stable as judged by the investigator for any significant medical condition.
- Be able to tolerate minimally invasive electrical stimulation.
Key exclusion criteria (21 listed)
- Severe cognitive impairment as determined by the Investigator.
- If female and sexually active, and the subject is not using a reliable form of birth control, is not surgically sterile or at least two years post-menopausal, the subject shall be excluded, as confirmed by the Investigator.
- If female, have a positive pregnancy test at the screening and/or Day 0 visit.
- Pre-existing motor, balance, proprioception, or sensory deficits as determined by Investigator.
- Show symptoms indicative of Covid-19 as assessed during enrollment.
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 |
|---|---|---|
| PNS Injectrode F1Also: InjectrodeThe PNS Injectrode F1 is a flexible conductor that conforms to the shape of a peripheral nerve and patient anatomy. The device is approximately 1 mm in overall diameter and is provided in lengths of 9 or 10 cm. The device is placed in a minimally invasive procedure via a standard 18g needle. The stimulating end of the device is placed in close proximity to the lumbar medial branch nerve with a collector end left subcutaneously. Electrical stimulation is provided via an externally placed patch electrode connected to the provided external pulse generator over the collector end of the device. Transcutaneous electrical stimulation will occur prior to device placement, on Day 0 after device placement, and on Day 25 prior to device removal. Minimally invasive removal is completed by a small incision and forceps using standard medical procedures and equipment. | Device | PNS Injectrode F1 |
Primary outcome
Incidence of Serious Adverse Device Effects (SADEs)
Time frame: 35 days
The safety endpoint will be the percentage of subjects that experience serious adverse device effects (SADE).
Proportion of Subjects with Multifidus Muscle Activation as determined by PI via Ultrasound Imaging and Palpation
Time frame: 25 days
The efficacy endpoint will be the proportion of subjects with a clinically meaningful activation of the multifidus muscle(s) unilaterally or bilaterally utilizing transcutaneous stimulation on Day 0 and on or before the Day 25 visit. Meaningful activation will be evaluated by the PI based on ultrasonic imaging as well as palpation.
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 Apr 2024.
- 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.
Amol Soin, MD, MBA principal investigator
The Ohio Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PNS Injectrode F1 in people with Chronic Pain and Lower Back Pain Chronic, run by Neuronoff, Inc 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 21 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 Apr 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of Serious Adverse Device Effects (SADEs) (time frame: 35 days). 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 16 Apr 2024.