Trigeminal NeuralgiaNCT01761604
A Nasal Applicator for the Treatment of Trigeminal Neuralgia
A study testing Nasal ganglion block for TN in people with Trigeminal Neuralgia, run by Chicago Anesthesia Pain Specialists at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Nasal ganglion block for TN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18- 80 years old
- Trigeminal Neuralgia
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago Anesthesia Pain Specialists
Chicago, Illinois, 60657
About this study
Official title: The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia
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.
Read the 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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Nasal ganglion block for TN
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal ganglion block for TNDevice
| Study group | Role | What they receive |
|---|---|---|
| Nasal ganglion block for TN | Other | Sphenopalatine ganglion block using the Tx360™ device Receives: Device: Nasal ganglion block for TN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity numeric rating scale
Change in pain intensity before procedure, baseline. And after procedure 15 minutes, 30 minutes, day 1, 7, 14, 21, and 28.
Measured: Before procedure and after procedure
Secondary outcomes (1)
Patient's global impression of change
Before procedure, baseline. And after procedure 30 minutes, day 1, 7, 14, 21, and 28.
Measured: After procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chicago Anesthesia Pain Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth D Candido, Chicago Anesthesia Pain Specialists
- Investigators
- Kenneth D Candido, M.D., Principal investigator, Chicago Anesthesia Pain Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761604
- Sponsor's protocol ID
- Advocate-IRB-5241
- Status last verified
- Sep 2017
- First submitted
- 2 Jan 2013
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT01761604
- Acronym / sponsor ID
- Advocate-IRB-5241
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chicago Anesthesia Pain SpecialistsUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal ganglion block for TN | Other | Device: Nasal ganglion block for TNSphenopalatine ganglion block using the Tx360™ device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18- 80 years old
- Trigeminal Neuralgia
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal ganglion block for TN | Device | Nasal ganglion block for TN |
Primary outcome
Pain intensity numeric rating scale
Time frame: Before procedure and after procedure
Change in pain intensity before procedure, baseline. And after procedure 15 minutes, 30 minutes, day 1, 7, 14, 21, and 28.
1 secondary outcome
Patient's global impression of change
Time frame: After procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth D Candido, M.D. principal investigator
Chicago Anesthesia Pain Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal ganglion block for TN in people with Trigeminal Neuralgia, run by Chicago Anesthesia Pain Specialists at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity numeric rating scale (time frame: Before procedure and after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.