Lumbar Injectrode Feasibility Evaluation
Public ClinicalTrials.gov record NCT06206356. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06206356
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 11, 2024
- Primary completion
- Mar 14, 2024
- Completion
- Mar 14, 2024
- Last update posted
- Apr 15, 2024
2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Ohio Pain Clinic | Dayton | Ohio | 45458 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06206356, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 15, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06206356 live on ClinicalTrials.gov.