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PNS Injectrode F1 for Chronic Pain (LIFE Trial)

Phase 1

Waitlist Available

Led By Amol Soin, MD, MBA

Research Sponsored by Neuronoff, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 21 years of age or older when written informed consent is obtained

Literate, able to speak English and able to complete questionnaires independently

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 35 days

Awards & highlights

LIFE Trial Summary

This trial aims to determine if using a device called the Neuronoff PNS Injectrode F1 on the lumbar medial branch nerve can activate a specific muscle in healthy volunteers. The trial will

Who is the study for?

This trial is for healthy volunteers experiencing chronic lower back pain. Participants must be willing to have the PNS Injectrode F1 device inserted near their lumbar medial branch nerve and keep it in place for up to 28 days. Specific inclusion and exclusion criteria details are not provided, but typically involve factors like age, health status, and other medical conditions.Check my eligibility

What is being tested?

The study tests if the Neuronoff PNS Injectrode F1 can be safely inserted and used to stimulate a specific back nerve (lumbar medial branch) to activate a muscle (multifidus). It involves transcutaneous stimulation before and after insertion of the device, which remains implanted for up to four weeks.See study design

What are the potential side effects?

While specific side effects are not listed, potential risks may include discomfort at the injection site, infection risk from implantation, possible allergic reactions or tissue damage due to electrical stimulation.

LIFE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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I can read, speak English, and fill out forms by myself.

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I can undergo minor electrical stimulation treatments.

LIFE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 35 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~35 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Serious Adverse Device Effects (SADEs)

Proportion of Subjects with Multifidus Muscle Activation as determined by PI via Ultrasound Imaging and Palpation

LIFE Trial Design

1Treatment groups

Experimental Treatment

Group I: PNS Injectrode F1Experimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ohio Pain ClinicOTHER

2 Previous Clinical Trials

25 Total Patients Enrolled

Neuronoff, IncLead Sponsor

1 Previous Clinical Trials

10 Total Patients Enrolled

Amol Soin, MD, MBAPrincipal InvestigatorThe Ohio Pain Clinic

1 Previous Clinical Trials

10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the total number of individuals involved in this medical study?

"Indeed, the details on clinicaltrials.gov confirm that this trial is actively seeking suitable candidates. The initial posting of the clinical trial was done on January 1st, 2024, and it has been recently updated as of January 12th, 2024. The study aims to enroll a total of 10 participants from one designated site."

Answered by AI

Has the PNS Injectrode F1 received clearance from the FDA for its use?

"Due to the limited data supporting safety and efficacy, our team at Power assigns a safety rating of 1 to PNS Injectrode F1. This is based on it being a Phase 1 trial."

Answered by AI

Is this medical study currently open for enrollment?

"Indeed, according to the information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted on January 1st, 2024 and most recently updated on January 12th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lumbar Injectrode Feasibility Evaluation

2024. "Lumbar Injectrode Feasibility Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06206356.

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