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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Trigeminal Neuralgia

In brief

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.

Key facts

Study ID

NCT02801630

Run by

Rosenblum, Jonathan I., DPM

People needed

60

Starts

2016-09-01

Expected to finish

2017-08-01

Last updated by the study team

2016-09-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Diagnosed with trigeminal neuralgia refractory to medical treatment (modified BNI V).

You may not qualify if…

• Male or female, under the age of 18. Active illicit drug use Pregnancy. Psychiatric illness which may prevent the patient from participation in the study.
• Anesthesia dolorosa with pain greater than or equal to 3/10 Dental implants. Other known pathology of the trigeminal nerve including iatrogenic anesthesia dolorosa.
• Cancer and bone metastases.

Where it is running

• NanoVibronix — Elmsford, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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