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Neurostimulation Device

Halo Craniofacial Nerve Stimulator System for Facial Pain

N/A
Waitlist Available
Research Sponsored by Curonix LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is ≥ 18 years of age at time of informed consent
Subjects have been diagnosed with Cranial-facial pain with an average VAS > 5 (on a 0-10 scale) over the course of the last month based on baseline pain diary.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will test whether a device that sends electrical signals to the craniofacial nerves can help relieve neuropathic pain.

Eligible Conditions
  • Facial Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events
Pain
Secondary outcome measures
Change from baseline in pain rating index from the Short Form McGill Pain Questionnaire (MPQ-SF-2)
Change from baseline in quality of life, Mental component score using Medical Outcomes Short Form SF-36
Change from baseline in quality of life, Physical component score using Medical Outcomes Short Form SF-36
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Continued Stimulation GroupExperimental Treatment1 Intervention
Subjects randomized to this group will have the Halo Craniofacial Nerve Stimulator System activated immediately.
Group II: Delayed Continuation GroupActive Control1 Intervention
Subjects randomized to this group with have the Halo Craniofacial Nerve Stimulator System activated after 90 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Halo Craniofacial Nerve Stimulator System
2017
N/A
~60

Find a Location

Who is running the clinical trial?

Curonix LLCLead Sponsor
6 Previous Clinical Trials
382 Total Patients Enrolled
Pennsylvania Hospital, Philadelphia, Pennsylvania, USAUNKNOWN
Minimally Invasive Pain Institute, Utica, New York, USAUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Mar 2025