Trigeminal NeuralgiaNCT05712993
Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers
A study testing V2 thermal radio frequency in people with Trigeminal Neuralgia, run by Iraqi Board of medical specialties at 1 site in Iraq.
Trial summary
new technique in targeting V2 under ultrasound guidance Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- V2 thermal radio frequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2021to 20 Aug 2022
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:above 40 severe pain normal neurological examination -
Exclusion Criteria:metastasis allergy to medication used radio frequency precautions previous failed radio frequency or microvascular decompression gamma knife coagulpathy sepsis or active infection at site of needle entry
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers to Localize the Maxillary Nerve Under Ultrasound Guidance
new technique in targeting V2 under ultrasound guidance
Read the detailed description
the classical approach of V2 transcoronoin for practitioner is considered as difficult with significant failure rate with sustained V3 motor stimulation our approach infrazygomatic anterior out of plane is considered much easier in achieving pure V2 stimulation without V3 which make the thermal radio frequency 80 Celsius can be performed safely
- Conditions
- Trigeminal Neuralgia
- Being tested
- V2 thermal radio frequency
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V2 thermal radio frequencyProcedure or surgery
V2 targeted thermal radio frequency safely without sustained V3 stimulation
| Study group | Role | What they receive |
|---|---|---|
| transcoronoid | Experimental | participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through coronoid notch Receives: Procedure: V2 thermal radio frequency |
| infrazygomatic anterior out of plane | Experimental | participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through infrazygomatic anterior out of plane Receives: Procedure: V2 thermal radio frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-efficacy and safety of infrazygomatic anterior out of plane 2- how can infrazygomatic maneuver can help in decrease the chance of targeting V3 in addition V2 during injection
new method used to target V2 to decrease the chance of failure and to lessen the number of trials required the tools of measurement was the stimulation in volt and number of trial by No.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Sep 2021
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iraqi Board of medical specialties
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712993
- Sponsor's protocol ID
- IraqBoard
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 40 participants enrolled in the study complaining of sever TN with normal neurological examination
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers to Localize the Maxillary Nerve Under Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT05712993
- Acronym / sponsor ID
- IraqBoard
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Iraqi Board of medical specialtiesUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 6 Feb 2023 (actual)
- 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.
new technique in targeting V2 under ultrasound guidance
Detailed description
the classical approach of V2 transcoronoin for practitioner is considered as difficult with significant failure rate with sustained V3 motor stimulation our approach infrazygomatic anterior out of plane is considered much easier in achieving pure V2 stimulation without V3 which make the thermal radio frequency 80 Celsius can be performed safely
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcoronoid | Experimental | Procedure: V2 thermal radio frequencyparticipants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through coronoid notch |
| infrazygomatic anterior out of plane | Experimental | Procedure: V2 thermal radio frequencyparticipants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through infrazygomatic anterior out of plane |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| V2 thermal radio frequencyV2 targeted thermal radio frequency safely without sustained V3 stimulation | Procedure or surgery | infrazygomatic anterior out of plane, transcoronoid |
Primary outcome
1-efficacy and safety of infrazygomatic anterior out of plane 2- how can infrazygomatic maneuver can help in decrease the chance of targeting V3 in addition V2 during injection
Time frame: 2 years
new method used to target V2 to decrease the chance of failure and to lessen the number of trials required the tools of measurement was the stimulation in volt and number of trial by No.
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 6 Feb 2023.
- Individual participant dataSharing planned: Undecided. 40 participants enrolled in the study complaining of sever TN with normal neurological examination
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V2 thermal radio frequency in people with Trigeminal Neuralgia, run by Iraqi Board of medical specialties at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Feb 2023. 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 Iraq. 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?
1-efficacy and safety of infrazygomatic anterior out of plane 2- how can infrazygomatic maneuver can help in decrease the chance of targeting V3 in addition V2 during injection (time frame: 2 years). 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 6 Feb 2023.