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Lumbar Injectrode Feasibility Evaluation

NCT06206356 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-16

No results posted yet for this study

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

Conditions

Interventions

DEVICE

PNS Injectrode F1

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.

Sponsors & Collaborators

  • Ohio Pain Clinic

    collaborator OTHER

  • Neuronoff, Inc

    lead INDUSTRY

Principal Investigators

  • Amol Soin, MD, MBA · The Ohio Pain Clinic

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2024-03-15
Completion
2024-03-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206356 on ClinicalTrials.gov