NCT02801630

An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rosenblum, Jonathan I., DPM · Individual
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a double blinded randomized control trial of a Surface acoustic wave patch device for the treatment of Trigeminal Neuralgia. All subjects will be enrolled for a 14 day lead up period, where baseline measures of pain, quality of life and analgesic use will be recorded. During the first month of the study subjects will be randomized into a sham or active device group. Both groups will be assessed every two weeks for pain, quality of life and analgesic use. After 4 weeks, those subjects in the sham group will be crossed over into the active group. Both groups will continue to be assessed biweekly through months 2 and 3. After 3 months of treatment a final assessment will be conducted and the results evaluated.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DEVICE	PainShield SAW Patch Device	The PainShield is a self contained Surface Acoustic Wave device, where the waves are delivered locally through a trasnducer embedded into a patch that sits on the affected area.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-06-16
• Last updated: 2016-09-27

Locations

1 site across 1 country: United States