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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801630
Recruitment Status : Unknown
Verified September 2016 by Rosenblum, Jonathan I., DPM.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Nanovibronix
Information provided by (Responsible Party):
Rosenblum, Jonathan I., DPM

Brief 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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Device: PainShield SAW Patch Device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia
Study Start Date : September 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham Crossover
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.
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.

Active Comparator: Active Device
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.
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.




Primary Outcome Measures :
  1. Pain [ Time Frame: 90 days ]
    The Patients level of pain will be assessed by Visual Analog Scale daily


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 90 days ]
    The patients satisfaction and quality of life will be measured by questionnaires including the SF-36

  2. Rescue Drug Use [ Time Frame: 90 days ]
    The patients use of rescue medication will be recorded during the duration of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801630


Contacts
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Contact: Jonathan Rosenblum +1-720-744-3222 diabfootman@gmail.com

Locations
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United States, New York
NanoVibronix Recruiting
Elmsford, New York, United States, 07055
Contact: Jonathan Rosenblum    720-744-3222    diabfootman@gmail.com   
Contact: william stern    9143765200 ext 3    william.stern@yahoo.com   
Sponsors and Collaborators
Rosenblum, Jonathan I., DPM
Nanovibronix
Investigators
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Study Director: William Stern Sponsor Representative

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Responsible Party: Rosenblum, Jonathan I., DPM
ClinicalTrials.gov Identifier: NCT02801630     History of Changes
Other Study ID Numbers: USTN1
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Trigeminal Nerve Diseases
Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases