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Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain

NCT02729480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-12

No results posted yet for this study

Summary

The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation for the treatment of neuropathic pain.

Conditions

  • Facial Pain

Interventions

DEVICE

Halo Craniofacial Nerve Stimulator System

The Halo Craniofacial Nerve Stimulator System is a wirelessly powered neurostimulator for pain in the face or head (not for headaches or migraine). This technology includes an implanted stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin to the receiver.

Sponsors & Collaborators

  • Goodman Campbell Brain and Spine, Indiana University, Indianapolis, Indiana, USA

    collaborator UNKNOWN

  • International Spine, Pain and Performance Center, Washington DC, USA

    collaborator UNKNOWN

  • Minimally Invasive Pain Institute, Utica, New York, USA

    collaborator UNKNOWN

  • Case Western Reserve University, Cleveland, Ohio, USA

    collaborator UNKNOWN

  • Pennsylvania Hospital, Philadelphia, Pennsylvania, USA

    collaborator UNKNOWN

  • Baylor College of Medicine

    collaborator OTHER

  • Prizm Pain Management, Canton, Michigan

    collaborator UNKNOWN

  • Curonix LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2022-02-01
Completion
2022-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02729480 on ClinicalTrials.gov