Last reviewed · How we verify
NCT06206356: LIFE
Lumbar Injectrode Feasibility Evaluation
Phase 1 trial testing PNS Injectrode F1 in Chronic Pain in 10 participants. Completed in 15 March 2024.
15 March 2024
Quick facts
| Lead sponsor | Neuronoff, Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 12 January 2024 |
| Primary completion | 15 March 2024 |
| Estimated completion | 15 March 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PNS Injectrode F1
Conditions studied
- Chronic Pain — all drugs for Chronic Pain →
- Lower Back Pain Chronic — all drugs for Lower Back Pain Chronic →
Sponsor
Neuronoff, Inc
Who can join
21 and older, any sex, with Chronic Pain or Lower Back Pain Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Abstracts from the Sixth Bioelectronic Medicine Summit: Neurotechnologies for Individuals and Communities.
· 2025 · PMID 41121432 · DOI 10.1186/s42234-025-00182-9
Verify or expand the search:
- PubMed search for NCT06206356
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Pain
Currently open trials in the same condition.
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- NCT07425691 — SPACE for Youth With Chronic Pain · recruiting
- NCT07103135 — Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling · Phase 1 · recruiting
- NCT06219408 — CIH Stepped Care for Co-occurring Chronic Pain and PTSD · NA · recruiting
- NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
Other Neuronoff, Inc trials
Trials by the same sponsor.
- NCT04672096 — Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06206356 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Neuronoff, Inc
- Last refreshed: 16 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06206356.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing