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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02801630
• Other study ID #: USTN1
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2016
• Last updated: September 26, 2016
• Start date: September 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2016
• Source: Rosenblum, Jonathan I., DPM
• Contact: Jonathan Rosenblum
• Phone: +1-720-744-3222
• Email: diabfootman[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

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.

Locations

Country	Name	City	State
United States	NanoVibronix	Elmsford	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rosenblum, Jonathan I., DPM	Nanovibronix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	The Patients level of pain will be assessed by Visual Analog Scale daily	90 days	No
Secondary	Quality of Life	The patients satisfaction and quality of life will be measured by questionnaires including the SF-36	90 days	No
Secondary	Rescue Drug Use	The patients use of rescue medication will be recorded during the duration of the study	90 days	No