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Lumbar Injectrode Feasibility Evaluation | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Lumbar Injectrode Feasibility Evaluation

NCT06206356•Neuronoff, Inc

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 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

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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.
+11 more criteria

Locations (1)

The Ohio Pain Clinic

Dayton, Ohio, United States

Key Dates

Start Date

January 12, 2024

Primary Completion Date

March 15, 2024

Completion Date

March 15, 2024

Last Updated

April 16, 2024

Enrollment

ACTUAL participants

Conditions

Chronic PainLower Back Pain Chronic

Interventions

PNS Injectrode F1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lumbar Injectrode Feasibility Evaluation

Inclusion Criteria

Exclusion Criteria

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