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Surface Acoustic Wave Patch Device

Active Device for Trigeminal Neuralgia

N/A
Waitlist Available
Research Sponsored by Rosenblum, Jonathan I., DPM
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This is a double blinded randomized control trial of a Surface Acoustic Wave Patch device for the treatment of Trigeminal Neuralgia. This will be a crossover study for the group that receives the sham device. Subjects will be monitored for subjective criteria of pain and quality of life, as well as objective measurement of analgesic usage.

Eligible Conditions
  • Trigeminal Neuralgia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Secondary outcome measures
Quality of Life
Rescue Drug Use

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active DeviceActive Control1 Intervention
After the enrollent and lead in period, subjects will be given an active PainSHield SAW Patch device to sleep with every night. They will be asked to fill out their pain and analgesic use logs, and undergo bi weekly assessments. They will continue to use the device while completing their logs and undergoing assessments for 3 months.
Group II: Sham CrossoverPlacebo Group1 Intervention
After the enrollment and lead in period, subjects will be given a sham device to sleep with every night for a month. They will be asked to fill out their pain and analgesic use logs, and undergo the bi weekly assessments. After a month they will be crossed over to an active "Painshield SAW patch device" and will continue to complete their pain and analgesic use logs as well as undergo biweekly assessments for months two and 3.

Find a Location

Who is running the clinical trial?

Rosenblum, Jonathan I., DPMLead Sponsor
3 Previous Clinical Trials
108 Total Patients Enrolled
NanovibronixIndustry Sponsor
6 Previous Clinical Trials
407 Total Patients Enrolled
William SternStudy DirectorSponsor Representative

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
NanoVibronix
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia
2016. "An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02801630.
All > Nerve Pain > Trigeminal Neuralgia
~7 spots leftby Apr 2025
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