NCT06206356

Lumbar Injectrode Feasibility Evaluation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Neuronoff, Inc · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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

• Chronic Pain
• Lower Back Pain Chronic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-12
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2024-01-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study