A Nasal Applicator for the Treatment of Trigeminal Neuralgia

This study is currently recruiting participants.
Verified January 2013 by Chicago Anesthesia Pain Specialists
Sponsor:
Information provided by (Responsible Party):
Kenneth D Candido, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier:
NCT01761604
First received: January 2, 2013
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily function and reduces quality of life. The sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures.

The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator device, in the treatment of TN. A local anesthetic will be delivered on the ganglion area. We are expecting that this new device will provide at least the same pain relief as the previously described approaches. However, this nasal applicator is intended to be an easy and non invasive method for office use.


Condition Intervention
Trigeminal Neuralgia
Device: Nasal ganglion block for TN

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia

Resource links provided by NLM:


Further study details as provided by Chicago Anesthesia Pain Specialists:

Primary Outcome Measures:
  • Pain intensity numeric rating scale [ Time Frame: Before procedure and after procedure ] [ Designated as safety issue: No ]
    Change in pain intensity before procedure, baseline. And after procedure 15 minutes, 30 minutes, day 1, 7, 14, 21, and 28.


Secondary Outcome Measures:
  • Patient's global impression of change [ Time Frame: After procedure ] [ Designated as safety issue: No ]
    Before procedure, baseline. And after procedure 30 minutes, day 1, 7, 14, 21, and 28.


Other Outcome Measures:
  • Modified Brief Pain inventory (short form) [ Time Frame: Before procedure and after procedure ] [ Designated as safety issue: No ]
    Before procedure, baseline. And after procedure day 1, 7, 14, 21, and 28.


Estimated Enrollment: 10
Study Start Date: December 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nasal ganglion block for TN
Sphenopalatine ganglion block using the Tx360™ device
Device: Nasal ganglion block for TN

Detailed Description:

The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily function and reduces quality of life. Pain severity correlates with reduced measures of daily functioning, and overall health status.

The sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures.

The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator device, in the treatment of TN. The Tx360™ is a single use nasal applicator that can reach the sphenopalatine ganglion area. It is designed to dispense medications through a flexible canula.

The patients with TN will receive a 0.5 mL spray of local anesthetic on the ganglion area, and measure the change in pain intensity and quality of life.

We are expecting that this new device will provide at least the same pain relief as the previously described approaches. However, this nasal applicator is intended to be an easy and non invasive method for office use.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18- 80 years old
  • Trigeminal Neuralgia

Exclusion Criteria:

  • Nasal septal deformity such as: cleft lip and palate, choanal atresia
  • Septal perforation
  • Recent nasal/midface trauma (< 3 months)
  • Bleeding disorder such as Von Willebrand's disease or hemophilia
  • Severe respiratory distress
  • Neoplasm such as the following: Angiofibroma, sinus Tumors, Granuloma
  • Congestion has been present more than 10 days, fever (define as temperature≥ 100.4 F)
  • Current cocaine user
  • Skin around and inside the nasal passage is dry, cracked, oozing, or bleeding
  • Allergy to marcaine
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761604

Contacts
Contact: N. Nick Knezevic, M.D., Ph. D. 773-296-7927 aimmc.anesthesia.research@gmail.com

Locations
United States, Illinois
Chicago Anesthesia Pain Specialists Recruiting
Chicago, Illinois, United States, 60657
Contact: N. Nick Knezevic, M.D., Ph.D.    773-296-7927    aimmc.anesthesia.research@gmail.com   
Principal Investigator: Kenneth D Candido, MD         
Sponsors and Collaborators
Chicago Anesthesia Pain Specialists
Investigators
Principal Investigator: Kenneth D Candido, M.D. Chicago Anesthesia Pain Specialists
  More Information

No publications provided

Responsible Party: Kenneth D Candido, Chairman of the Anesthesia Department at Advocate Illinois Masonic Medical Center, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier: NCT01761604     History of Changes
Other Study ID Numbers: Advocate-IRB-5241
Study First Received: January 2, 2013
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trigeminal Nerve Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on April 17, 2014