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Surface Acoustic Wave Patch Device
An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of 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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain
Secondary study objectives
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.
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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
409 Total Patients Enrolled
William SternStudy DirectorSponsor Representative